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

University of Michigan Rogel Cancer Center60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Interventions

Behavioral InterventionBEHAVIORAL

Undergo SFBT-C

Best PracticeOTHER

Receive eTAU

Communication InterventionOTHER

Receive check in calls from clinician

DiscussionOTHER

Participate in discussions

Health Promotion and EducationOTHER

Receive educational manual

Health Promotion and EducationOTHER

Receive educational book

InterviewOTHER

Ancillary studies

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At baseline, immediate post-intervention, and 4 and 8 weeks post-intervention

Secondary Outcomes

Patient's level of hope

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.

Time frame: Baseline to 8 weeks

Quality of life

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.

Time frame: At baseline, immediate post-intervention, and 4 and 8 weeks post intervention