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

NCT06194786 | Unknown DMC

• 1 other identifier: 04/2023
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

Diet; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• overall survival

  12-2 months

• Disease free survival

  12-24 months

Study Arms (3)

Group A

EXPERIMENTAL

Dietary and physical activity

Behavioral: Group D

Group B

EXPERIMENTAL

Dietary only

Behavioral: Group D

Group C

EXPERIMENTAL

Physical activity only

Behavioral: Group D

Interventions

Group D BEHAVIORAL

Usual care

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Habib Bourguiba University Hospital: lead
• National cancer institute -Misurata: collaborator

Study Sites (1)

Wala Ben Kridis

Sfax, 3029, Tunisia

Location

Related Publications (1)

• Aboturkia AM, Ben Kridis W, Aqoup MO, Abdoalmola MO, Ben Ali S, Khanfir A. Diet and physical activity in colorectal cancer patients: A research protocol of a randomized controlled study. World J Gastrointest Oncol. 2025 Aug 15;17(8):109579. doi: 10.4251/wjgo.v17.i8.109579.

  PMID: 40837756 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: May 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

TU (1)