The RAISE Study: Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll
研究概览
简要总结
The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer. First, the study team will adapt an evidence-supported, group-based program for improving psychological resiliency (Stress Management and Resiliency Training - Relaxation Response Resiliency Program; SMART-3RP (E. R. Park et al., 2021)), and iteratively incorporate feedback from parents of AYAs with cancer using a mixed-methods approach. Next, the study team will pilot the refined intervention to assess for preliminary indicators of feasibility, acceptability, and potential for efficacy in reducing parental distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifying parent/guardian who provides a primary informal caregiving role in their child's cancer
- •Recipient of caregiving is aged between 15 and 39 years and is receiving treatment for cancer at the Mass General Brigham Cancer
- •Participant must score equal to or greater than 2 (out of a possible 10) on the National Comprehensive Cancer Network Distress Thermometer
- •English-speaking
- •Aged over 18 years
排除标准
- •Active symptoms of psychosis or suicidal ideation that would preclude safe participation
研究组 & 干预措施
Psychosocial Intervention for Parental Caregivers of AYA with Cancer-open pilot study
The study team aims to evaluate the feasibility and acceptability of the adapted psychosocial intervention to 1) improve psychological resiliency to stress and 2) reduce symptoms of depression, anxiety, and post-traumatic stress among parental caregivers, through a single-arm open pilot trial of 32 parents.
干预措施: Psychosocial Intervention for Parental Caregivers of AYA with Cancer (Behavioral)
结局指标
主要结局
Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll
时间窗: Post-treatment completion (enrollment to treatment completion is approximately 3 months)
Percent of eligible participants who were offered participation and who enroll in the study by completing consent and baseline assessment.
Intervention Feasibility: Proportion of Participants Completing the Program
时间窗: Post-treatment completion (enrollment to treatment completion is approximately 3 months)
Percent of enrolled participants who complete the program, defined as completing 6 out of 8 sessions.
Intervention Acceptability
时间窗: Post-treatment completion (enrollment to treatment completion is approximately 3 months)
Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The intervention study will be considered acceptable if ≥80% of participants rate it as acceptable (defined as a CSQ-8 score ≥20).
次要结局
未报告次要终点
研究者
Zeba Ahmad, Ph.D.
Clinical Staff Psychologist
Massachusetts General Hospital