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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorUniversity of Michigan Rogel Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioral Intervention

    Behavioral

    Undergo SFBT-C

  • Best Practice

    Other intervention

    Receive eTAU

  • Communication Intervention

    Other intervention

    Receive check in calls from clinician

  • Discussion

    Other intervention

    Participate in discussions

  • Health Promotion and Education

    Other intervention

    Receive educational manual

  • Health Promotion and Education

    Other intervention

    Receive educational book

  • Interview

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Supportive Care (eTAU)Active comparator 4 interventions
Group B: Supportive Care (SFBT-C)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Children's Cancer Research Fund

Collaborator