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

Colorectal Cancer Clinical Trial

— DPAP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06194786
• Other study ID #: 04/2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: January 2024
• Source: Habib Bourguiba University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: May 15, 2025
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Group D
Usual care

Locations

Country	Name	City	State
Tunisia	Wala Ben Kridis	Sfax

Sponsors (2)

Lead Sponsor	Collaborator
Habib Bourguiba University Hospital	National cancer institute -Misurata

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity target-cancer outcome	accelerometer or stopwatch or phone timer	0-6-12-18-24 months
Primary	Dietary target-red meat	food frequency questionnaire	0-6-12-18-24 months
Secondary	overall survival	time between randomization and date of last news	12-2 months
Secondary	Disease free survival	time between randomization and progression	12-24 months