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Clinical Trials/NCT06194786
NCT06194786
Enrolling By Invitation
Not Applicable

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

Habib Bourguiba University Hospital1 site in 1 country260 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Habib Bourguiba University Hospital
Enrollment
260
Locations
1
Primary Endpoint
physical activity target-cancer outcome
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
May 15, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Habib Bourguiba University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wala Ben Kridis

Principal Investigator

Habib Bourguiba University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

physical activity target-cancer outcome

Time Frame: 0-6-12-18-24 months

accelerometer or stopwatch or phone timer

Dietary target-red meat

Time Frame: 0-6-12-18-24 months

food frequency questionnaire

Secondary Outcomes

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

Study Sites (1)

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