Trial Outcomes & Findings for The HOPE Trial and the SMART Study (NCT NCT03022032)
NCT ID: NCT03022032
Last Updated: 2025-09-09
Results Overview
This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
30 days
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
HOPE Pre-Pilot
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Refined Smartphone App and Accelerometer (HOPE)
Participants received the FitBit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
Wearable Accelerometer (HOPE)
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Refined Smartphone App (HOPE)
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
Usual Care (HOPE)
The HOPE app will collect passive data from the smartphone.
|
SMART Study Arm
Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
23
|
21
|
22
|
22
|
4
|
|
Overall Study
COMPLETED
|
10
|
23
|
21
|
22
|
22
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The HOPE Trial and the SMART Study
Baseline characteristics by cohort
| Measure |
Comparing Steps Collected by Accelerometer (HOPE)
n=10 Participants
* 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
* All participants will receive :
* HOPE App
* The Fitbit Zip
* The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2
Fitbit Zip: Fitbit Zip
HOPE App: HOPE App
Fitbit Charge 2: Fitbit Charge 2
|
Refined Smartphone App and Accelerometer (HOPE)
n=23 Participants
* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
Participants will be asked to wear the Fitbit
-The Hope App will measure daily steps The app will also collect passive data from the smartphone
HOPE App: HOPE App
|
Wearable Accelerometer (HOPE)
n=21 Participants
* Participants will be asked to wear the Fitbit
* The Hope App will measure daily steps
* The app will also collect passive data from the smartphone
HOPE App: HOPE App
Fitbit Charge 2: Fitbit Charge 2
|
Refined Smartphone App (HOPE)
n=22 Participants
* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
* The app will also collect passive data from the smartphone
HOPE App: HOPE App
|
Usual Care (HOPE)
n=22 Participants
Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
* Usual care
* The app will also collect passive data from the smartphone
HOPE App: HOPE App
Standard of Care: Standard of Care
|
SMART Study Arm
n=4 Participants
* Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
* The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
* The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
* The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.
SMART Study Intervention: SMART study app + Beiwe study app + Fitbit
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.29 • n=39 Participants
|
61.52 years
STANDARD_DEVIATION 13.36 • n=41 Participants
|
63.76 years
STANDARD_DEVIATION 8.43 • n=35 Participants
|
62.09 years
STANDARD_DEVIATION 8.19 • n=31 Participants
|
59.64 years
STANDARD_DEVIATION 9.31 • n=146 Participants
|
65.50 years
STANDARD_DEVIATION 8.85 • n=19 Participants
|
60.75 years
STANDARD_DEVIATION 10.07 • n=147 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
102 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
99 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Marital Status
Married
|
8 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
14 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
64 Participants
n=147 Participants
|
|
Marital Status
Divorced/Separated
|
0 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
15 Participants
n=147 Participants
|
|
Marital Status
Never Married
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
14 Participants
n=147 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
7 Participants
n=147 Participants
|
|
Marital Status
Missing
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
|
Race
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
5 Participants
n=147 Participants
|
|
Race
Black or African American
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
7 Participants
n=147 Participants
|
|
Race
Native Hawaiian or Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race
White
|
6 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
83 Participants
n=147 Participants
|
|
Race
Other
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
|
Race
Don't know
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race
Refuse to answer
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Last grade level completed
8th grade or less
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Last grade level completed
9 - 11th grade
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Last grade level completed
High school graduate or GED
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
9 Participants
n=147 Participants
|
|
Last grade level completed
Vocational or Technical training
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
|
Last grade level completed
Associate degree or some college
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
25 Participants
n=147 Participants
|
|
Last grade level completed
Bachelor's degree
|
0 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
27 Participants
n=147 Participants
|
|
Last grade level completed
Advanced degree
|
6 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
38 Participants
n=147 Participants
|
|
Last grade level completed
Other
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Last grade level completed
Don't know
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Last grade level completed
Refused
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: 30 daysThis outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."
Outcome measures
| Measure |
HOPE Pre-pilot
n=10 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Feasibility - (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week
|
9 Participants
|
—
|
—
|
—
|
|
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Acceptability - (1) "Participating in this study placed a substantial burden on me."
|
1 Participants
|
—
|
—
|
—
|
|
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Acceptability - (2) "I wish I had not agreed to participate in this study."
|
1 Participants
|
—
|
—
|
—
|
|
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Feasibility - (1) greater than or equal to 60% enrollment rate among eligible patients approached
|
10 Participants
|
—
|
—
|
—
|
|
Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
Feasibility - (2) greater than or equal to 70% adherence to daily smartphone surveys
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This outcome was limited to the HOPE pilot, consisting of 10 patients.
This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.
Outcome measures
| Measure |
HOPE Pre-pilot
n=10 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
Preferred FitBit Charge
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
Preferred FitBit Zip
|
1 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 90 daysSMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
Outcome measures
| Measure |
HOPE Pre-pilot
n=4 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 90 daysSMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."
Outcome measures
| Measure |
HOPE Pre-pilot
n=4 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
Acceptability - (1) "Participating in this study placed a substantial burden on me."
|
0 Participants
|
—
|
—
|
—
|
|
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
Acceptability - (2) "I wish I had not agreed to participate in this study."
|
0 Participants
|
—
|
—
|
—
|
|
Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
Acceptability - (3) "I would recommend the application to a friend going through treatment."
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. \[The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Anxiety as Assessed by GAD-7 (HOPE RCT)
Baseline
|
3.43 GAD-7 Total score
Standard Deviation 2.98
|
3.74 GAD-7 Total score
Standard Deviation 4.19
|
5.45 GAD-7 Total score
Standard Deviation 4.82
|
4.10 GAD-7 Total score
Standard Deviation 3.43
|
|
Anxiety as Assessed by GAD-7 (HOPE RCT)
30 days post-baseline
|
3.17 GAD-7 Total score
Standard Deviation 3.24
|
5.09 GAD-7 Total score
Standard Deviation 4.46
|
2.64 GAD-7 Total score
Standard Deviation 2.54
|
4.00 GAD-7 Total score
Standard Deviation 2.24
|
|
Anxiety as Assessed by GAD-7 (HOPE RCT)
90 days post-baseline
|
3.50 GAD-7 Total score
Standard Deviation 3.55
|
3.38 GAD-7 Total score
Standard Deviation 4.03
|
2.92 GAD-7 Total score
Standard Deviation 2.47
|
3.07 GAD-7 Total score
Standard Deviation 2.13
|
|
Anxiety as Assessed by GAD-7 (HOPE RCT)
180 days post-baseline
|
0.78 GAD-7 Total score
Standard Deviation 0.97
|
3.78 GAD-7 Total score
Standard Deviation 4.09
|
3.00 GAD-7 Total score
Standard Deviation 2.26
|
3.22 GAD-7 Total score
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Depression as Assessed by PHQ-9 (HOPE RCT)
Baseline
|
4.43 PHQ-9 total score
Standard Deviation 3.73
|
3.70 PHQ-9 total score
Standard Deviation 3.48
|
4.95 PHQ-9 total score
Standard Deviation 3.61
|
5.59 PHQ-9 total score
Standard Deviation 4.62
|
|
Depression as Assessed by PHQ-9 (HOPE RCT)
30 days post-baseline
|
3.20 PHQ-9 total score
Standard Deviation 4.18
|
4.58 PHQ-9 total score
Standard Deviation 4.46
|
3.27 PHQ-9 total score
Standard Deviation 2.90
|
4.80 PHQ-9 total score
Standard Deviation 3.38
|
|
Depression as Assessed by PHQ-9 (HOPE RCT)
90 days post-baseline
|
5.90 PHQ-9 total score
Standard Deviation 4.95
|
4.58 PHQ-9 total score
Standard Deviation 5.04
|
3.46 PHQ-9 total score
Standard Deviation 3.26
|
3.87 PHQ-9 total score
Standard Deviation 1.96
|
|
Depression as Assessed by PHQ-9 (HOPE RCT)
180 days post-baseline
|
1.22 PHQ-9 total score
Standard Deviation 1.39
|
3.56 PHQ-9 total score
Standard Deviation 4.00
|
3.42 PHQ-9 total score
Standard Deviation 2.43
|
5.09 PHQ-9 total score
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
Baseline
|
142.1 Total score
Standard Deviation 24.3
|
147.0 Total score
Standard Deviation 23.2
|
139.7 Total score
Standard Deviation 22.4
|
139.4 Total score
Standard Deviation 21.1
|
|
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
30 days post-baseline
|
150.7 Total score
Standard Deviation 22.0
|
145.7 Total score
Standard Deviation 26.4
|
147.4 Total score
Standard Deviation 19.6
|
145.6 Total score
Standard Deviation 18.7
|
|
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
90 days post-baseline
|
132.3 Total score
Standard Deviation 27.2
|
143.8 Total score
Standard Deviation 34.3
|
150.9 Total score
Standard Deviation 20.1
|
141.0 Total score
Standard Deviation 18.4
|
|
Patient Well-being as Assessed by FACIT-Pal (HOPE RCT)
180 days post-baseline
|
161.4 Total score
Standard Deviation 15.6
|
155.2 Total score
Standard Deviation 22.8
|
144.1 Total score
Standard Deviation 17.7
|
140.4 Total score
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
10 Participants
|
6 Participants
|
10 Participants
|
11 Participants
|
|
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
5 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
2 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
4 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
10 Participants
|
8 Participants
|
7 Participants
|
11 Participants
|
|
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
5 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
12 Participants
|
7 Participants
|
11 Participants
|
12 Participants
|
|
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
7 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
7 Participants
|
1 Participants
|
6 Participants
|
11 Participants
|
|
Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
2 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
10 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
|
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
8 Participants
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
6 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
|
Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
5 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
6 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
|
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
1 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
12 Participants
|
8 Participants
|
10 Participants
|
16 Participants
|
|
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
5 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
6 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
7 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
5 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants with available data at each time point.
Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Baseline
|
7 Participants
|
7 Participants
|
12 Participants
|
15 Participants
|
|
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
30 days post-baseline
|
3 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
90 days post-baseline
|
5 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
180 days post-baseline
|
2 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 90 days, 180 days (Phase II)Population: Participants who had both physician- and patient-reported ECOG Performance Status (PS) assessed at baseline and/or follow-up timepoints.
Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation.
Outcome measures
| Measure |
HOPE Pre-pilot
n=23 Participants
10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.
|
Arm 2: Fitbit+Passive App
n=21 Participants
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Arm 3: Active App
n=22 Participants
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms
|
Arm 4: Passive App
n=22 Participants
The HOPE app will collect passive data from the smartphone.
|
|---|---|---|---|---|
|
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
Baseline
|
0.70 Weighted Kappa (no unit)
|
0.48 Weighted Kappa (no unit)
|
0.35 Weighted Kappa (no unit)
|
0.39 Weighted Kappa (no unit)
|
|
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
30 days post-baseline
|
0.24 Weighted Kappa (no unit)
|
0.59 Weighted Kappa (no unit)
|
0.61 Weighted Kappa (no unit)
|
0.34 Weighted Kappa (no unit)
|
|
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
90 days post-baseline
|
0.20 Weighted Kappa (no unit)
|
0.31 Weighted Kappa (no unit)
|
-0.15 Weighted Kappa (no unit)
|
0.17 Weighted Kappa (no unit)
|
|
Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
180 days post-baseline
|
-0.08 Weighted Kappa (no unit)
|
0.71 Weighted Kappa (no unit)
|
0.24 Weighted Kappa (no unit)
|
0.25 Weighted Kappa (no unit)
|
Adverse Events
HOPE Pre-Pilot
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Refined Smartphone App and Accelerometer (HOPE)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Wearable Accelerometer (HOPE)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Refined Smartphone App (HOPE)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Usual Care (HOPE)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 2 deaths
SMART Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HOPE Pre-Pilot
n=10 participants at risk
10 patients will be enrolled in stage 1 to refine the HOPE App intervention; All participants will receive: HOPE App, The Fitbit Zip, The Fitbit Charge 2
The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2.
Fitbit Zip: Fitbit Zip HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2
|
Refined Smartphone App and Accelerometer (HOPE)
n=23 participants at risk
Participants received the Fitbit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
Wearable Accelerometer (HOPE)
n=21 participants at risk
Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.
|
Refined Smartphone App (HOPE)
n=22 participants at risk
Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
Usual Care (HOPE)
n=22 participants at risk
The HOPE app will collect passive data from the smartphone.
|
SMART Study Arm
n=4 participants at risk
Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
43.5%
10/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
52.4%
11/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
45.5%
10/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
45.5%
10/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
21.7%
5/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
23.8%
5/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
18.2%
4/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
13.6%
3/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
34.8%
8/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
38.1%
8/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
31.8%
7/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
40.9%
9/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Gastrointestinal disorders
Vomit
|
10.0%
1/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
13.0%
3/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
9.5%
2/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
13.6%
3/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
13.6%
3/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Nervous system disorders
Neuropathy
|
40.0%
4/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
52.2%
12/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
61.9%
13/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
45.5%
10/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
36.4%
8/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
13.0%
3/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
4.8%
1/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
4.5%
1/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
0.00%
0/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
47.8%
11/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
42.9%
9/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
40.9%
9/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
50.0%
11/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Nervous system disorders
Anxiety
|
80.0%
8/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
78.3%
18/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
85.7%
18/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
77.3%
17/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
72.7%
16/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Nervous system disorders
Depression
|
80.0%
8/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
47.8%
11/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
38.1%
8/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
40.9%
9/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
40.9%
9/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
|
Nervous system disorders
Fatigue
|
100.0%
10/10 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
95.7%
22/23 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
90.5%
19/21 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
95.5%
21/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
77.3%
17/22 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
—
0/0 • HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place