Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of Physical Activity Intervention
研究概览
简要总结
The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.
Participants will be asked to:
- Complete surveys to assess bowel function and quality of life
- Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
- Perform daily physical activity
详细描述
The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
- •Age 18 or older
- •Three months to 5 years post-treatment completion
- •Have a rectal or anal anastomosis with a LARS score of 21-42
- •At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
- •Ability to be physically active and cleared by MD
- •Patients must be able to read and understand English.
- •Participants must sign the informed consent form
- •The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue 20 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded, or additional studies may be performed to investigate those differences more fully.
排除标准
- •Patients failing to meet all the above inclusion criteria will be excluded from the study.
结局指标
主要结局
Feasibility of Physical Activity Intervention
时间窗: From enrollment to the end of treatment at 12 weeks.
Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).
次要结局
- Acceptability and Participant Satisfaction with Physical Activity Intervention(From enrollment to the end of treatment after 12 weeks.)
- Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome.(At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.)
研究者
Erica Pettke, MD, MPH, FACS
Physician
Abramson Cancer Center at Penn Medicine