Trial Outcomes & Findings for Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management (NCT NCT02460822)
NCT ID: NCT02460822
Last Updated: 2017-05-11
Results Overview
Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.
COMPLETED
NA
16 participants
8 weeks post-enrollment
2017-05-11
Participant Flow
Participant milestones
| Measure |
MyChemoCare
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MyChemoCare
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Baseline characteristics by cohort
| Measure |
MyChemoCare
n=16 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post-enrollmentPatient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.
Outcome measures
| Measure |
MyChemoCare
n=16 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Patient Retention and Engagement With the MyChemoCare Application
Completed the 8-week trial
|
15 Participants
|
|
Patient Retention and Engagement With the MyChemoCare Application
Checked in at least 1 time per week
|
12 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post enrollmentThe investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app. This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree.
Outcome measures
| Measure |
MyChemoCare
n=15 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Patient Satisfaction and Usability of the MyChemoCare Application
|
3.95 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 8 weeks post-enrollmentThe investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.
Outcome measures
| Measure |
MyChemoCare
n=16 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Physician Use of the Study Feedback Mechanism
|
16 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post enrollmentThe investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed. The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified.
Outcome measures
| Measure |
MyChemoCare
n=15 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Increased Mastery of Cancer and Chemotherapy Symptoms
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post enrollmentThe investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items. The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified.
Outcome measures
| Measure |
MyChemoCare
n=15 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Symptom Burden Reduction
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post enrollmentThe investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well). The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified.
Outcome measures
| Measure |
MyChemoCare
n=15 Participants
Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application
|
|---|---|
|
Improved Quality of Life
|
9 Participants
|
Adverse Events
MyChemoCare
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place