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

NCT06941324 | Recruiting DMC

• 3 other identifiers: UMCC 2024.086NCI-2025-01196HUM00254795
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C)

  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 Outcomes (2)

• Patient's level of hope

  Baseline to 8 weeks

• Quality of life

  At baseline, immediate post-intervention, and 4 and 8 weeks post intervention

Study Arms (2)

Supportive Care (eTAU)

ACTIVE COMPARATOR

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: Best Practice; Other: Communication Intervention; Other: Health Promotion and Education; Other: Questionnaire Administration

Supportive Care (SFBT-C)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Discussion; Other: Health Promotion and Education; Other: Interview; Other: Questionnaire Administration

Interventions

Communication Intervention OTHER

Receive check in calls from clinician

Supportive Care (eTAU)

Discussion OTHER

Participate in discussions

Also known as: Discuss

Supportive Care (SFBT-C)

Health Promotion and Education OTHER

Receive educational manual

Supportive Care (SFBT-C)

Interview OTHER

Ancillary studies

Supportive Care (SFBT-C)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (SFBT-C); Supportive Care (eTAU)

Behavioral Intervention BEHAVIORAL

Undergo SFBT-C

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Supportive Care (SFBT-C)

Best Practice OTHER

Receive eTAU

Also known as: standard of care, standard therapy

Supportive Care (eTAU)

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Children's Cancer Research Fund: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Behavior Therapy; Practice Guidelines as Topic; Standard of Care; Health Promotion; Educational Status; Interviews as Topic

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Anao Zhang

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)