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

January 5, 2024 updated by: Wala Ben Kridis, Habib Bourguiba University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 0-6-12-18-24 months
accelerometer or stopwatch or phone timer
0-6-12-18-24 months
Dietary target-red meat
Time Frame: 0-6-12-18-24 months
food frequency questionnaire
0-6-12-18-24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Habib Bourguiba University Hospital

Collaborators

National cancer institute -Misurata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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