Colon CancerColofit+NCT03276091
Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test
A study testing Colofit+ intervention in people with Colon Cancer, run by Patricia Soler-Michel at 1 site in France.
Trial summary
Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. Read more about this study
- Who is it for?
- Ages 51 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Colofit+ intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2017to 16 Mar 2018
- 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 51 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)
Who cannot join
- colonoscopy done
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study
Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.
- Conditions
- Colon Cancer
- Being tested
- Colofit+ intervention
- Keywords
- colonoscopy, immunochemical fecal test, screening
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colofit+ interventionBehavioural
Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| COLOFIT+ Study | Experimental | Personnalized motivational phone call, done by a medical physician Receives: Behavioral: Colofit+ intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation to the colonoscopy
Colonoscopy done six months after our phone call
Measured: From date of phone call until the date of first documented colonoscopy assessed up to 6 months
Secondary outcomes (2)
reasons for rejecting colonoscopy
we will ask to patients why they don't realized their colonoscopy
Measured: Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
cancer and adenoma detected
number of cancer and adenoma detected during colonoscopy
Measured: From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start23 May 2017
- Primary completion31 Dec 2017
- Study completion16 Mar 2018
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 Colon 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patricia Soler-Michel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricia Soler-Michel, Association pour le Dépistage Organisé des Cancers dans le Rhône
- Investigators
- Thierry Ponchon, PHD, Study director, Hopital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276091
- Sponsor's protocol ID
- IDRCB 2017-A00635-48
- Acronym
- Colofit+
- Status last verified
- Jul 2018
- First submitted
- 6 Sep 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gandilhon C, Soler-Michel P, Vecchiato L, Chaunier C, Fay I, Walter T, Rivory J, Saurin JC, Ponchon T, Pioche M. A motivational phone call improves participation to screening colonoscopy for those with a positive FIT in a national screening programme (NCT 03276091). Dig Liver Dis. 2018 Dec;50(12):1309-1314. doi: 10.1016/j.dld.2018.08.007. Epub 2018 Aug 17.
PubMed 30197186
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study
- ClinicalTrials.gov ID
- NCT03276091
- Acronym / sponsor ID
- Colofit+ / IDRCB 2017-A00635-48
- Conditions
- Colon Cancer
- Keywords
- colonoscopy, immunochemical fecal test, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Patricia Soler-MichelUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 8 Sep 2017 (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.
Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COLOFIT+ Study | Experimental | Behavioral: Colofit+ interventionPersonnalized motivational phone call, done by a medical physician |
Who may qualify
- Ages
- 51 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)
Key exclusion criteria (1 listed)
- colonoscopy done
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 |
|---|---|---|
| Colofit+ interventionPersonnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy. | Behavioural | COLOFIT+ Study |
Primary outcome
Participation to the colonoscopy
Time frame: From date of phone call until the date of first documented colonoscopy assessed up to 6 months
Colonoscopy done six months after our phone call
2 secondary outcomes
reasons for rejecting colonoscopy
Time frame: Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
cancer and adenoma detected
Time frame: From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Derived from this study: PubMed 30197186Gandilhon C, Soler-Michel P, Vecchiato L, Chaunier C, Fay I, Walter T, Rivory J, Saurin JC, Ponchon T, Pioche M. A motivational phone call improves participation to screening colonoscopy for those with a positive FIT in a national screening programme (NCT 03276091). Dig Liver Dis. 2018 Dec;50(12):1309-1314. doi: 10.1016/j.dld.2018.08.007. Epub 2018 Aug 17.
- Individual participant dataSharing planned: No
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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.
Thierry Ponchon, PHD study director
Hopital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colofit+ intervention in people with Colon Cancer, run by Patricia Soler-Michel at 1 site in France.
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: finished, as of the sponsor's last update on 3 Jul 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participation to the colonoscopy (time frame: From date of phone call until the date of first documented colonoscopy assessed up to 6 months). 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 NCT03276091, 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 3 Jul 2018.