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

NCT ID: NCT06941324

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive eTAU

Communication Intervention

Intervention Type OTHER

Receive check in calls from clinician

Health Promotion and Education

Intervention Type OTHER

Receive educational book

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Undergo SFBT-C

Discussion

Intervention Type OTHER

Participate in discussions

Health Promotion and Education

Intervention Type OTHER

Receive educational manual

Interview

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Undergo SFBT-C

Intervention Type BEHAVIORAL

Best Practice

Receive eTAU

Intervention Type OTHER

Communication Intervention

Receive check in calls from clinician

Intervention Type OTHER

Discussion

Participate in discussions

Intervention Type OTHER

Health Promotion and Education

Receive educational manual

Intervention Type OTHER

Health Promotion and Education

Receive educational book

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments standard of care standard therapy Discuss

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Cancer Research Fund

OTHER

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anao Zhang

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer AnswerLine

Role: CONTACT

Phone: 1-800-865-1125

Email: [email protected]

Facility Contacts

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Cancer AnswerLine

Role: primary

Other Identifiers

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NCI-2025-01196

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUM00254795

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2024.086

Identifier Type: -

Identifier Source: org_study_id