Colorectal CancerNCT02855385
Barriers to Care in Patients With Rectal Bleeding in Nigeria
An observational study of Colorectal Cancer, run by Obafemi Awolowo University Teaching Hospital.
Trial summary
This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum. 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
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Nov 2014
- How long will I take part?
- 60 Days
- Phase
- Observational
- 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
Study population: All patients with Rectal bleeding who consented to the study
Who may be able to join
- All adult patients with rectal bleeding that persisted for up to one month
Who cannot join
- Patient that has the cause of rectal bleeding already determined before presentation
About this study
Official title: Health-seeking Behavior and Barriers to Care in Patients With Rectal Bleeding in Nigeria
This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.
Read the detailed description
Patients who had rectal bleeding are invited to electronic media and print media will be invited for free medical consultation. Consented patients will complete a purposely design questionnaire for the study to assess the knowledge, attitude and practice of patient with rectal bleeding as regard the possibility of occurrence of colorectal cancer.
General practitioners in three cities will be contacted to assess their screening strategy for patients with rectal bleeding
- Conditions
- Colorectal Cancer
- Keywords
- Rectal bleeding, , ,, Attitude, Health seeking behaviour, Nigeria, Screening, high risk patients
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Hemorrhage, Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | This are patients who have current or previous history of rectal bleeding | |
| General Practitioner group | This are General practitioner who are in public or private hospitals who treat patients with rectal bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score in relations to the demographics of patients with rectal bleeding
To investigates patients' knowledge of the causes of rectal bleeding and their attitudes towards seeking expert opinion for possible diagnostic testing for colorectal cancer (CRC)
Measured: 60 days
Colonoscopy referral triggers among General Practitioners (GP)
To seeks to examine the GPs' perceived barriers to colonoscopy for patients with bleeding per rectum
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of Ilorin Teaching Hospital, University College Hospital, Ibadan
- Responsible party
- Principal investigator, Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855385
- Sponsor's protocol ID
- ERC/2013/09/01
- Status last verified
- Aug 2016
- First submitted
- 28 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-seeking Behavior and Barriers to Care in Patients With Rectal Bleeding in Nigeria
- ClinicalTrials.gov ID
- NCT02855385
- Acronym / sponsor ID
- ERC/2013/09/01
- Conditions
- Colorectal Cancer
- Keywords
- Rectal bleeding, , ,, Attitude, Health seeking behaviour, Nigeria, Screening, high risk patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of Ilorin Teaching Hospital, University College Hospital, Ibadan
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Aug 2016 (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.
This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.
Detailed description
Patients who had rectal bleeding are invited to electronic media and print media will be invited for free medical consultation. Consented patients will complete a purposely design questionnaire for the study to assess the knowledge, attitude and practice of patient with rectal bleeding as regard the possibility of occurrence of colorectal cancer.
General practitioners in three cities will be contacted to assess their screening strategy for patients with rectal bleeding
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –This are patients who have current or previous history of rectal bleeding |
| General Practitioner group | – | –This are General practitioner who are in public or private hospitals who treat patients with rectal bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Rectal bleeding who consented to the study
Key inclusion criteria (1 listed)
- All adult patients with rectal bleeding that persisted for up to one month
Key exclusion criteria (1 listed)
- Patient that has the cause of rectal bleeding already determined before presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge score in relations to the demographics of patients with rectal bleeding
Time frame: 60 days
To investigates patients' knowledge of the causes of rectal bleeding and their attitudes towards seeking expert opinion for possible diagnostic testing for colorectal cancer (CRC)
Colonoscopy referral triggers among General Practitioners (GP)
Time frame: 60 days
To seeks to examine the GPs' perceived barriers to colonoscopy for patients with bleeding per rectum
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 4 Aug 2016.
- Individual participant dataSharing planned: Undecided. Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Obafemi Awolowo University Teaching Hospital.
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 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge score in relations to the demographics of patients with rectal bleeding (time frame: 60 days). 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?
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 4 Aug 2016.