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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Group D

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Sfax, Tunisia, 3029
    • Wala Ben Kridis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Dietary and physical activity	Behavioral: Group D; Usual care
Experimental: Group B; Dietary only	Behavioral: Group D; Usual care
Experimental: Group C; Physical activity only	Behavioral: Group D; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity target-cancer outcome	accelerometer or stopwatch or phone timer	0-6-12-18-24 months
Dietary target-red meat	food frequency questionnaire	0-6-12-18-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	time between randomization and date of last news	12-2 months
Disease free survival	time between randomization and progression	12-24 months

Collaborators and Investigators

• Sponsor: Habib Bourguiba University Hospital
• Collaborators: National cancer institute -Misurata

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 04/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No