Virtual Mindful After Cancer Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Recruitment Accrual Rate- The percent of eligible candidates who enroll
研究概览
简要总结
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns.
The main study aims are to:
- Develop effective plans for recruiting participants across multiple sites
- Evaluate participation in the program and surveys
- Develop plans to train and supervise the professionals who will deliver the program.
Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial.
Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program.
Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey.
All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Diagnosed with female breast or gynecologic cancer at stage I-IV
- •Diagnosed at least 6 months ago
- •At least one sexual concern in a validated screener
- •Access to high speed internet via smart phone, tablet, and/or computer
排除标准
- •Those who do not comprehend English since the MAC program is only available in English.
研究组 & 干预措施
Usual Care
Intervention
干预措施: Mindful After Cancer Program (Behavioral)
结局指标
主要结局
Recruitment Accrual Rate- The percent of eligible candidates who enroll
时间窗: Baseline
Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist.
时间窗: Up to 1 week post-intervention.
Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session.
Retention Rate - The percent of enrolled participants who complete all study surveys
时间窗: Up to the 3 month post-intervention survey at week 22.
Recruitment Accrual Rate- The percent of eligible candidates who enroll
时间窗: Baseline
次要结局
- MAC intervention Drop Out- As measured by session attendance.(Up to completion of the 8-week MAC intervention.)
研究者
Jessica Gorman
Associate Professor
Oregon State University