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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06194786
Acronym
DPAP
Enrollment
260
Registered
2024-01-08
Start date
2023-05-15
Completion date
2025-05-15
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Diet, Physical activity

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).

Interventions

BEHAVIORALGroup D

Usual care

Sponsors

National cancer institute -Misurata
CollaboratorUNKNOWN
Habib Bourguiba University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
physical activity target-cancer outcome0-6-12-18-24 monthsaccelerometer or stopwatch or phone timer
Dietary target-red meat0-6-12-18-24 monthsfood frequency questionnaire

Secondary

MeasureTime frameDescription
overall survival12-2 monthstime between randomization and date of last news
Disease free survival12-24 monthstime between randomization and progression

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026