Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients

Cancer Clinical Trial

Official title:

Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04773197
• Other study ID #: UMCC 2019.159
• Secondary ID: HUM00165949
• Status: Terminated
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: August 3, 2021

Study information

• Verified date: December 2021
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Depression
• Depression, Anxiety

Intervention

Behavioral:
• Beating the Blues (BtB)
Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
• Entertain Me Well (EMW)
Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
• Coaching
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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	St. Baldrick's Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of C-CBT completion	Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.	10 weeks
Primary	Percentage of participants who confirm acceptability of the intervention during interviews	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	Change in level of depression from baseline to end of intervention	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
Secondary	Change in level of anxiety from baseline to end of intervention	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
Secondary	Change in level of distress from baseline to end of intervention	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
Secondary	Change in level of self-efficacy from baseline to end of intervention	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
Secondary	Change in level of involvement and participation in health care from baseline to end of intervention	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