Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in psychological well-being
研究概览
简要总结
The Purpose Project intervention is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.
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
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 25 and 74 years of age
- •Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
- •English speaking
- •Graduated from high school
- •Able to see, hear, speak (with or without assistive devices)
- •Able to provide own transportation to sessions
- •Willing and able to commit to attend all 8 intervention sessions, 2 testing sessions, and the one-to-one interview that occurs after completing the 8 intervention sessions.
排除标准
- •Stage 4 breast cancer or any other stage 4 cancer
- •Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
- •History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
- •Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
研究组 & 干预措施
Purpose Project Group
Group receiving Purpose Project intervention.
干预措施: Purpose Project (Behavioral)
结局指标
主要结局
Change in psychological well-being
时间窗: Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, \& Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
次要结局
- Recruitment(Up to 1 month after IRB approval)
- Time of testing session(Each week from week 2 through week 8, approximately 2.5 hours at each session)
- Participant Experience of Purpose Project(At week 12 and at week 14-20)
- Intervention fidelity(Each week from week 2 through week 8)
- Time of pre-testing session(Duration of pre-testing session (approximately 2 hours) at week 0 to week 1)
- Time of post-testing session(Duration of session 8 (at week 12), approximately 2 hours)
- Change in Satisfaction with Participation in Discretionary Social Activities(At week 0 and at week 12)
- Purpose Status and Expectations(At Week 12)
- Homework completion(Each week from week 2 through week 8)
- Change in Meaning in life(At week 0 and at week 12)
- Engagement in Meaningful Activities(At week 0 and at week 12)
研究者
Mary Radomski
Senior Scientific Advisor
Allina Health System