Colorectal CancerDPAPNCT06194786
Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial
A study testing Group D in people with Colorectal Cancer, run by Habib Bourguiba University Hospital at 1 site in Tunisia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Group D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Group D
- Keywords
- Diet, Physical activity
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dietary and physical activity Receives: Behavioral: Group D |
| Group B | Experimental | Dietary only Receives: Behavioral: Group D |
| Group C | Experimental | Physical activity only Receives: Behavioral: Group D |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity target-cancer outcome
accelerometer or stopwatch or phone timer
Measured: 0-6-12-18-24 months
Dietary target-red meat
food frequency questionnaire
Measured: 0-6-12-18-24 months
Secondary outcomes (2)
overall survival
time between randomization and date of last news
Measured: 12-2 months
Disease free survival
time between randomization and progression
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 May 2023
- Primary completion15 May 2023
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habib Bourguiba University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National cancer institute -Misurata
- Responsible party
- Principal investigator, Wala Ben Kridis, Habib Bourguiba University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194786
- Sponsor's protocol ID
- 04/2023
- Acronym
- DPAP
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40837756
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06194786
- Acronym / sponsor ID
- DPAP / 04/2023
- Conditions
- Colorectal Cancer
- Keywords
- Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Habib Bourguiba University HospitalUniversity, hospital or other
- Collaborators
- National cancer institute -Misurata
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Group DDietary and physical activity |
| Group B | Experimental | Behavioral: Group DDietary only |
| Group C | Experimental | Behavioral: Group DPhysical activity only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group DUsual care | Behavioural | Group A, Group B, Group C |
Primary outcome
physical activity target-cancer outcome
Time frame: 0-6-12-18-24 months
accelerometer or stopwatch or phone timer
Dietary target-red meat
Time frame: 0-6-12-18-24 months
food frequency questionnaire
2 secondary outcomes
overall survival
Time frame: 12-2 months
Disease free survival
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 40837756Aboturkia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group D in people with Colorectal Cancer, run by Habib Bourguiba University Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity target-cancer outcome (time frame: 0-6-12-18-24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.