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

NCT04773197 | Terminated DMC

• 2 other identifiers: UMCC 2019.159HUM00165949
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Anxiety; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change in level of depression from baseline to end of intervention

  10 weeks

• Change in level of anxiety from baseline to end of intervention

  10 weeks

• Change in level of distress from baseline to end of intervention

  10 weeks

• Change in level of self-efficacy from baseline to end of intervention

  10 weeks

• Change in level of involvement and participation in health care from baseline to end of intervention

  10 weeks

Study Arms (3)

Coach-assisted C-CBT with BtB

EXPERIMENTAL

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.

Behavioral: Beating the Blues (BtB); Behavioral: Coaching

Coach-assisted animated C-CBT with EMW

ACTIVE COMPARATOR

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.

Behavioral: Entertain Me Well (EMW); Behavioral: Coaching

Standard stand-alone C-CBT with BtB

ACTIVE COMPARATOR

Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance.

Behavioral: Beating the Blues (BtB)

Interventions

Beating the Blues (BtB) BEHAVIORAL

Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Coach-assisted C-CBT with BtB; Standard stand-alone C-CBT with BtB

Entertain Me Well (EMW) BEHAVIORAL

Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Coach-assisted animated C-CBT with EMW

Coaching BEHAVIORAL

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.

Coach-assisted C-CBT with BtB; Coach-assisted animated C-CBT with EMW

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cancer survivor, either receiving active treatment or completed cancer treatment
• Experiencing depression and anxiety as measured by PHQ-9 or GAD-7

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• St. Baldrick's Foundation: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Anao Zhang, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a three-arm, prospective randomized controlled trial with participants being randomly assigned into one of the three groups: (1) coach-assisted BtB intervention (treatment condition 1), (2) coach-assisted animated EMW (treatment condition 2), and (3) standard BtB (control group).

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: November 30, 2020
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)