A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
研究概览
简要总结
This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.
详细描述
The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.
The 3RP has not yet been carried out with adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.
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
- None
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with any cancer between ages 14 and 29
- •Completed cancer treatment within the past 5 years
- •At least 16 years of age at time of enrollment
排除标准
- •Unwilling or unable to participate in the study
- •Unable to speak or read English
- •Is medically or otherwise unable to participate (as determined by a physician or study PI)
- •Unwilling or unable to participate in study sessions delivered via the Partners Telehealth videoconferencing software
- •Participation in a focus group during Phase 1 (DF/HCC 17-315)
研究组 & 干预措施
Waitlist Control
- The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
- Mini relaxation practice
- Weekly goal check-ins
- RR-practice
干预措施: Waitlist control (Other)
3RP Group Sessions
- The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
- Mini relaxation practice
- Weekly goal check-ins
- RR-practice
干预措施: 3RP-AYA (Other)
结局指标
主要结局
3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
时间窗: Post-treatment completion (treatment is approximately 8 weeks)
Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
时间窗: Post-treatment completion (treatment is approximately 8 weeks)
Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.
3RP-AYA Acceptability: Five Questions
时间窗: Post-treatment completion (treatment is approximately 8 weeks)
Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.
次要结局
未报告次要终点
研究者
Giselle K. Perez Lougee
Principal Investigator
Massachusetts General Hospital