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临床试验/NCT06194786
NCT06194786Enrolling By Invitation不适用

Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial

Habib Bourguiba University Hospital2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
260
试验地点
2
主要终点
physical activity target-cancer outcome

研究概览

简要总结

Colorectal cancers (CRC) represent the 1st digestive cancer and the 3rd cancer in the world. The World Cancer Research Fund summarized evidence from observational studies and concluded that low dietary fiber, and high red and processed meat (RPM) intakes were associated with higher risk of (CRC), whilst physical activity (PA) protected against developing colon cancer.

Post-treatment management is essential for improving the health and quality of life of colorectal cancer (CRC) survivors. The number of cancer survivors is continually increasing, which is causing a corresponding growth in the need for effective post- treatment management programs. To date, there is insufficient information available from the published literature as to the most effective way in promoting lifestyle changes in CRC survivors. Moreover, none of these interventions have been conducted in an African population. We aim to assess whether the proposed program may effectively modify the targeted behaviors, to evaluate whether the dietary and PA interventions of the "Moving Bright, Eating Smart" program are effective in reducing the consumption of red and processed meat (RPM) and refined grain (RG), increasing the physical activity (PA) levels in north African (Libyan and Tunisian) adult colorectal cancer (CRC) survivors and to assess the efficacy of behavioral interventions on cancer outcomes (overall survival, disease free survival).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven colorectal adenocarcinoma patients above the age of 18 years within one year of completion of main cancer treatment who are able to provide informed consent.

排除标准

  • Colorectal cancer patients who have persistent or recurrent disease at the time of the recruitment, are receiving cancer treatment, have known contraindication to physical activity, have psychiatric disease.

结局指标

主要结局

physical activity target-cancer outcome

时间窗: 0-6-12-18-24 months

accelerometer or stopwatch or phone timer

Dietary target-red meat

时间窗: 0-6-12-18-24 months

food frequency questionnaire

次要结局

  • overall survival(12-2 months)
  • Disease free survival(12-24 months)

研究者

发起方
Habib Bourguiba University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wala Ben Kridis

Principal Investigator

Habib Bourguiba University Hospital

研究点 (2)

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