Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Detailed description
07JUL2026- Amendment approved updating the study PI to Dr. Sunnye Mayes.
Interventions
BEHAVIORALBehavioral Intervention
Undergo SFBT-C
OTHERBest Practice
Receive eTAU
OTHERCommunication Intervention
Receive check in calls from clinician
OTHERDiscussion
Participate in discussions
OTHERHealth Promotion and Education
Receive educational manual
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Children's Cancer Research Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's level of hope | 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. |
| Quality of life | 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. |
Countries
United States
Contacts
CONTACTCancer AnswerLine
PRINCIPAL_INVESTIGATORSunnye Mayes
University of Michigan Rogel Cancer Center
Outcome results
None listed