Solution-Focused Brief Therapy for Support of Psychological Distress in Adolescent and Young Adult Cancer Survivors

July 14, 2026 updated by: University of Michigan Rogel Cancer Center

SFBT for AYA Cancer Survivors' Psychological Distress: Evaluating Solution-Focused Brief Therapy as a Strength-Based Psychotherapeutic Intervention for Psychological Distress in Adolescents and Young Adults With Cancer

This clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (SFBT-C) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. Cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. Consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. SFBT-C is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. Undergoing SFBT-C may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

07JUL2026- Amendment approved updating the study PI to Dr. Sunnye Mayes.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Sunnye Mayes

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 15 - 39 years old
  • Diagnosed with cancer
  • Receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship
  • Experiencing psychological distress (i.e., a t-score >= 57 on the Brief Symptom Inventory - 18 items [BSI-18])
  • Fluent in English

Exclusion Criteria:

  • End-of-life care
  • > 5 years into the post-treatment survivorship
  • Major physical challenges (e.g., hearing loss, developmental delay)
  • Acute mental health conditions (e.g., active psychosis, suicide risk)
  • Receiving or newly initiated psychotherapy for psychological distress during the study period

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supportive Care (eTAU)
Patients receive eTAU and receive an educational book to address emotional challenges associated with cancer and strategies and resources to address these challenges over 4-8 weeks on study. Additionally, patients receive check in calls from clinicians QW to answer any questions patients may have about the book.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive eTAU
Other Names:
  • standard of care
  • standard therapy
Other: Communication Intervention
Receive check in calls from clinician
Other: Health Promotion and Education
Receive educational manual
Other: Health Promotion and Education
Receive educational book
Experimental: Supportive Care (SFBT-C)
Patients undergo virtual SFBT sessions over 30 minutes each QW over 4-8 weeks on study. Patients also receive an educational manual and participate in discussions after each session on study.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Discussion
Participate in discussions
Other Names:
  • Discuss
Other: Health Promotion and Education
Receive educational manual
Other: Health Promotion and Education
Receive educational book
Behavioral: Behavioral Intervention
Undergo SFBT-C
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C)
Time Frame: At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention
The primary analysis will be a linear regression model with the change score from baseline (T1) to 4 weeks post-intervention completion (T3) in participants' Brief Symptom Inventory, 18-item (BSI-18) t-score as the dependent variable, the intervention assignment, and the randomization strata (age and sex) as the independent variables, i.e., covariates to control for.
At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's level of hope
Time Frame: Baseline to 8 weeks
Will be measured using Snyder's Hope Scale (SHS). Will use structural equation modeling (in Mplus) to perform mediation analysis. The primary analysis will be a simple mediation model with the T1 to 8 weeks post-intervention (T4) BSI-18 change score as the dependent variable, treatment assignment as the independent variable, and SHS at immediate post-intervention (T2) as the mediator. An estimated indirect effect (i.e., joint significance testing with bootstrapped standard error) will be computed, and its corresponding 95% confidence interval will determine if hope is a significant treatment mediator.
Baseline to 8 weeks
Quality of life
Time Frame: At baseline, immediate post-intervention, and 4 and 8 weeks post intervention
Measured by Patient Reported Outcomes Measurement Information System-29 Profile version 2.0. The primary analysis will be a linear regression model with the change score from T1 to T3 (4-week post) in participants' BSI-18 t-score as the dependent variable, the intervention assignment, and the randomization strata (age and sex) as the independent variables, i.e., covariates to control for.
At baseline, immediate post-intervention, and 4 and 8 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Children's Cancer Research Fund

Investigators

  • Principal Investigator: Sunnye Mayes, University of Michigan Rogel Cancer Center

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)

June 23, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2024.086
  • NCI-2025-01196 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HUM00254795 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share the study protocol, statistical analysis plan, and analytic codes after a reasonable request and with the discretion of the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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