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NCT Number: NCT06941324

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

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.

Recruiting

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Cancer AnswerLine

CONTACT

[email protected]

800-865-1125

Sunnye Mayes

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

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

Best Practice

Other

Receive eTAU

Other names: standard of care, standard therapy

Communication intervention

Other

Receive check in calls from clinician

Discussion

Other

Participate in discussions

Other names: Discuss

Health Promotion and Education

Other

Receive educational manual

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer AnswerLine

CONTACT

[email protected]

1-800-865-1125

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Children's Cancer Research Fund

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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