HealthyEarly Phase 1NCT00431327
Facilitators to Keeping Colonoscopy Appointments
A Early Phase 1 study testing Peer coach phone call in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Peer coach phone call
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Oct 2006
- Phase
- Early Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50
- No prior colonoscopy in our health system records
- Patient in one of four primary care clinics within the University of Pennsylvania Health System
- Attended <75 of their primary care physicians visits within the past year
Who cannot join
- Colonoscopy not ordered by a primary care physician in a study clinic
- High readiness for the procedure
- A health care professional
- Had a prior colonoscopy outside of our health care system
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Peer Coach Intervention to Improve Attendance to Scheduled Colonoscopy
To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.
Read the detailed description
The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient 'peer coach' who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.
- Conditions
- Healthy
- Being tested
- Peer coach phone call
- Keywords
- patient navigator, peer support, colonoscopy, adherence, None: have to be scheduled for screening or diagnostic colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer coach phone callBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Attending the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startFeb 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Barbara J Turner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431327
- Sponsor's protocol ID
- 705823
- Status last verified
- May 2023
- First submitted
- 1 Feb 2007
- Last updated
- 24 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Coach Intervention to Improve Attendance to Scheduled Colonoscopy
- ClinicalTrials.gov ID
- NCT00431327
- Acronym / sponsor ID
- 705823
- Conditions
- Healthy
- Keywords
- patient navigator, peer support, colonoscopy, adherence, None: have to be scheduled for screening or diagnostic colonoscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Oct 2006
- First posted
- 5 Feb 2007 (estimated)
- 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.
To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.
Detailed description
The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient 'peer coach' who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50
- No prior colonoscopy in our health system records
- Patient in one of four primary care clinics within the University of Pennsylvania Health System
- Attended <75 of their primary care physicians visits within the past year
Key exclusion criteria (4 listed)
- Colonoscopy not ordered by a primary care physician in a study clinic
- High readiness for the procedure
- A health care professional
- Had a prior colonoscopy outside of our health care system
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 |
|---|---|---|
| Peer coach phone call | Behavioural | – |
Primary outcome
Attending the colonoscopy
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 24 May 2023.
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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.
Barbara J Turner, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Peer coach phone call in people with Healthy, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 4 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 24 May 2023. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attending the colonoscopy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.