- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773197
Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
December 16, 2021 updated by: University of Michigan Rogel Cancer Center
This project's overall goal is to test the feasibility, acceptability and efficacy of two coach-assisted, computer-based, cognitive- behavioral therapy (C-CBT) interventions in treating depression and anxiety in adolescent and young adult cancer survivors.
The two coach-assisted interventions will be compared to the standard C-CBT intervention.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This will be a three-arm randomized controlled trial with two treatment arms and one control arm.
Participants in the first treatment arm will receive a coach-assisted C-CBT intervention called "Beating the Blues" (BtB).
A second treatment arm will receive a coach-assisted, animated C-CBT intervention called "Entertain Me Well" (EMW).
Both treatment arms will have 8 weekly sessions that contain core components of CBT.
A coach will provide between-session support throughout the 8 sessions.
The control arm will use the standard care of BtB without coach assistance.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cancer survivor, either receiving active treatment or completed cancer treatment
- Experiencing depression and anxiety as measured by PHQ-9 or GAD-7
Exclusion Criteria:
- Severe medical or mental condition (e.g. suicidal ideation)
- Medical condition that prevents patients from operating a computer or tablet
- Receiving end-of-life care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coach-assisted C-CBT with BtB
Participants will receive coach- assisted Beating the Blues (BtB), a C- CBT program, which contains 8 weekly sessions.
A coach will provide between session support throughout the 8 sessions.
|
Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program.
They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.
|
Active Comparator: Coach-assisted animated C-CBT with EMW
Participants will receive coach- assisted Entertain Me Well (EMW), an animated C-CBT program, which contains 8 weekly sessions.
A coach will provide between session support throughout the 8 sessions.
|
A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program.
They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.
Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
|
Active Comparator: Standard stand-alone C-CBT with BtB
Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance.
|
Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of C-CBT completion
Time Frame: 10 weeks
|
Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.
|
10 weeks
|
Percentage of participants who confirm acceptability of the intervention during interviews
Time Frame: 10 weeks
|
Participants will be interviewed about their perceptions regarding the delivery format, treatment content, and other treatment related factors.
Qualitative interviews will be transcribed by research staff and coded using thematic content analysis and axial coding.
Qualitative data will be reviewed iteratively until saturation is reached, that is when no new information seems to emerge during coding.
Emergence or non-emergence of acceptability theme will be assessed.
Findings will be descriptive and will include the percentage of participants who confirm acceptability.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in level of depression from baseline to end of intervention
Time Frame: 10 weeks
|
The Patient Health Questionnaire, 9 -item (PHQ-9) is a validated brief measure of depression.
Participants will answer the questionnaire at their baseline assessment, at the beginning of each session, and at their post-intervention assessment.
|
10 weeks
|
Change in level of anxiety from baseline to end of intervention
Time Frame: 10 weeks
|
The Generalized Anxiety Disorder, 7-item (GAD-7) is a validated brief measure of anxiety.
Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
|
10 weeks
|
Change in level of distress from baseline to end of intervention
Time Frame: 10 weeks
|
The Brief Symptom Inventory, 18-item (BSI-18) is a validated distress screening tool especially for cancer patients.
Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
|
10 weeks
|
Change in level of self-efficacy from baseline to end of intervention
Time Frame: 10 weeks
|
The PROMIS Self-Efficacy for Managing Chronic Conditions (PROMIS SM Scale) is a 28-item validated tool to assess patients' self-efficacy in managing their chronic condition symptoms.
|
10 weeks
|
Change in level of involvement and participation in health care from baseline to end of intervention
Time Frame: 10 weeks
|
The Patient Activation Measure (PAM) is a 13-item validated tool to evaluate patients' involvement and participation in their health care.
Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anao Zhang, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Actual)
August 3, 2021
Study Completion (Actual)
August 3, 2021
Study Registration Dates
First Submitted
February 23, 2021
First Submitted That Met QC Criteria
February 23, 2021
First Posted (Actual)
February 26, 2021
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
December 16, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2019.159
- HUM00165949 (Other Identifier: University of Michigan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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