Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial
- Conditions
- Colorectal Cancer
- Interventions
- Behavioral: Group D
- Registration Number
- NCT06194786
- Lead Sponsor
- Habib Bourguiba University Hospital
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 260
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group B Group D Dietary only Group A Group D Dietary and physical activity Group C Group D Physical activity only
- Primary Outcome Measures
Name Time Method physical activity target-cancer outcome 0-6-12-18-24 months accelerometer or stopwatch or phone timer
Dietary target-red meat 0-6-12-18-24 months food frequency questionnaire
- Secondary Outcome Measures
Name Time Method Disease free survival 12-24 months time between randomization and progression
overall survival 12-2 months time between randomization and date of last news
Trial Locations
- Locations (1)
Wala Ben Kridis
🇹🇳Sfax, Tunisia