About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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])
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Behavioral Intervention
BehavioralUndergo SFBT-C
Best Practice
Other interventionReceive eTAU
Communication Intervention
Other interventionReceive check in calls from clinician
Discussion
Other interventionParticipate in discussions
Health Promotion and Education
Other interventionReceive educational manual
Health Promotion and Education
Other interventionReceive educational book
Interview
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial 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.
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.
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.
Sponsors and contacts
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University of Michigan Rogel Cancer Center
Lead sponsor
Children's Cancer Research Fund
Collaborator