Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Acceptability assessed by semi-structured interview
研究概览
简要总结
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
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
- 21 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 rectosigmoid colon or rectum
- •6 months post-treatment completion
- •Have a permanent ostomy or anastomosis
- •English-speaking
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients with stage IV disease will be excluded from the study
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Acceptability assessed by semi-structured interview
时间窗: Up to 6 months
Will be assessed through qualitative data analysis using conventional content analysis approach.
Quality of life assessed by City of Hope-Quality of Life-Colorectal Cancer
时间窗: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
时间窗: Up to 6 months
Descriptive statistics will be summarized using validated scoring procedures.
Feasibility assessed by patient enrollment
时间窗: Up to 6 months
Will be assessed through: 1) the ratio of eligible participants to those enrolled and those who declines participation; 2) reasons for non-participation; 3) number of scheduled study encounters completed; 4) attrition rate between pre- and post-intervention; 5) reasons for attrition/dropout; 6) level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions; and 7) the ratio of all participants to those who complete \>= 80% of the study.
次要结局
未报告次要终点