SFBT for AYA Cancer Survivors' Psychological Distress: Evaluating Solution-Focused Brief Therapy as a Strength-Based Psychotherapeutic Intervention for Psychological Distress in Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C)
研究概览
简要总结
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.
详细描述
07JUL2026- Amendment approved updating the study PI to Dr. Sunnye Mayes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Behavioral Intervention (Behavioral)
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.
干预措施: Best Practice (Other)
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.
干预措施: Communication Intervention (Other)
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.
干预措施: Health Promotion and Education (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Discussion (Other)
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.
干预措施: Health Promotion and Education (Other)
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.
干预措施: Interview (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Efficacy of solution-focused brief therapy in cancer survivors (SFBT-C)
时间窗: 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.
次要结局
- Patient's level of hope(Baseline to 8 weeks)
- Quality of life(At baseline, immediate post-intervention, and 4 and 8 weeks post intervention)