Trial Outcomes & Findings for Mobile App of CBT for Anxiety and Cancer (NCT NCT02286466)
NCT ID: NCT02286466
Last Updated: 2018-08-28
Results Overview
Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)
Results posted on
2018-08-28
Participant Flow
Participants were screened and enrolled at Massachusetts General Hospital Cancer Center in Boston, MA and Lee Memorial Regional Cancer Center in Fort Myers, FL.
Participant milestones
| Measure |
CBT Mobile Application
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
73
|
|
Overall Study
Baseline Clinician Assessment
|
72
|
72
|
|
Overall Study
Post Self-report
|
67
|
68
|
|
Overall Study
COMPLETED
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
CBT Mobile Application
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Declined Clinician Assessment
|
0
|
1
|
Baseline Characteristics
Mobile App of CBT for Anxiety and Cancer
Baseline characteristics by cohort
| Measure |
CBT Mobile Application
n=72 Participants
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
n=73 Participants
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.86 years
STANDARD_DEVIATION 10.08 • n=99 Participants
|
57.03 years
STANDARD_DEVIATION 12.42 • n=107 Participants
|
56.45 years
STANDARD_DEVIATION 11.30 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
67 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American or Black
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 0
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 1
|
39 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 2
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cancer type
Gastrointestinal
|
23 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Cancer type
Gynecologic
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Cancer type
Lung
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Cancer type
Breast
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Cancer type
Melanoma
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Cancer type
Sarcoma
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Cancer type
Genitourinary
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Cancer type
Peritoneal
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cancer type
Thyroid
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hamilton Anxiety Rating Scale (HAM-A).
Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.
Outcome measures
| Measure |
CBT Mobile Application
n=65 Participants
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
n=63 Participants
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Change in Anxiety Symptoms From Baseline to Post-assessment
|
-2.99 Units on a scale
Standard Error 0.96
|
-1.85 Units on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Functional Assessment of Cancer Therapy-General (FACT-G).
Functional Assessment of Cancer Therapy-General: The FACT-G is a valid and reliable self-report, 27-item instrument, consisting of 4 subscales that evaluate physical, functional, emotional and social wellbeing during the past 7 days. Items are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate better quality of life, while lower scores indicate worse quality of life.
Outcome measures
| Measure |
CBT Mobile Application
n=67 Participants
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
n=66 Participants
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Change in Quality of Life From Baseline to Post-assessment
|
7.88 Units on a scale
Standard Error 1.76
|
7.87 Units on a scale
Standard Error 1.77
|
SECONDARY outcome
Timeframe: 1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hospital Anxiety \& Depression Scale (HADS).
Hospital Anxiety \& Depression Scale (HADS): The HADS is a self-report instrument that was designed for medical patients and demonstrates adequate psychometric properties for use among individuals with cancer. Comprised of 14-items that are scored on a 4-point Likert scale, the instrument contains two subscales that measure anxiety and depression symptoms in the past week. Total scores for each subscale range from 0 (no distress) to 21 (maximum distress).
Outcome measures
| Measure |
CBT Mobile Application
n=67 Participants
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
n=68 Participants
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Change in Mood Symptoms From Baseline to Post-assessment
HADS-Anxiety Subscale
|
-4.33 Units on a scale
Standard Error 0.44
|
-3.55 Units on a scale
Standard Error 0.44
|
|
Change in Mood Symptoms From Baseline to Post-assessment
HADS-Depression Subscale
|
-1.89 Units on a scale
Standard Error 0.39
|
-1.41 Units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: 1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)Population: Analysis population is the number of participants who completed both baseline and post-assessment measures of the Patient Health Questionnaire-9 (PHQ-9).
Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a brief, validated measure of major depression per the criteria of the Diagnostic and Statistical Manual of Mental Disorders. Patients respond to 9 questions on a scale of 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27, with higher scores indicating worse depression symptoms.
Outcome measures
| Measure |
CBT Mobile Application
n=67 Participants
The presence and usage of a CBT Mobile Application.
CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
|
Health Education Program
n=68 Participants
The presence and usage of Health Education Program.
Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
|
|---|---|---|
|
Change in Depression Symptoms From Baseline to Post-assessment
|
-2.29 Units on a scale
Standard Error 0.57
|
-2.14 Units on a scale
Standard Error 0.57
|
Adverse Events
CBT Mobile Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Health Education Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joseph Greer, PhD
Massachusetts General Hospital Cancer Center
Phone: 617-643-2143
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place