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

Habib Bourguiba University Hospital

Status: Invitation-only

Conditions: Colorectal Cancer

Treatments: Behavioral: Group D

Study type: Interventional

Funder types: Other

Identifiers

NCT06194786

04/2023

Details and patient eligibility

About

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).

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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260 participants in 3 patient groups

Group A

Experimental group

Description:

Dietary and physical activity

Treatment:

Behavioral: Group D

Group B

Experimental group

Description:

Dietary only

Treatment:

Behavioral: Group D

Group C

Experimental group

Description:

Physical activity only

Treatment:

Behavioral: Group D