Colorectal CancerNCT02534142
Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence
An observational study of Colorectal Cancer, run by Meuhedet. Healthcare Organization at 1 site in Israel.
Trial summary
Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Read more about this study
- Who is it for?
- Ages 51 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 774 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to 20 Dec 2017
- 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 51 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: a representative sample of Meuhedet members who adhered / did not adhere to followup of a positive fecal occult blood test using colonoscopy
Who may be able to join
- Members of MHC aged 50-74 who completed a fecal occult blood test during the study period.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Using both quantitative and qualitative methods, the investigators will identify organisational and personal barriers to completion of followup of positive FOBT.
Read the detailed description
Colorectal cancer is the second in incidence and mortality among malignant tumors. Early detection of the disease is an effective means of reducing mortality and is possible through a fecal occult blood test. In the case of a positive result colonoscopy is required. In Israel, about 30% of people with a positive occult blood test do not perform a follow-up test.
The aim of the study is to identify existing barriers to undergoing colonoscopy in a normal-risk population and improving adherence through different intervention mechanisms. At the end of the study we will describe effective intervention models at three levels: the patient, physicians and the organisation to improve early detection of colon cancer.
Innovation of the Study
- It will focus on the normal-risk population groups in Israel with a positive occult blood that didn't undergo colonoscopy.
- Will identify the barriers in diverse populations
- Will review the accessibility of diagnostic facilities forcolon cancer in Israel.
- Will propose intervention programs to improve adherence at all levels in the process.
Study Methods: A prospective study sing both both quantitative and qualitative methods in Meuhedet Health Services Target Population: Health system managers, physicians, and patients (a representative sample of 200 patients adhere colonoscopy and 600 that didn't adhere). Data collection databases from Meuhedet. The study will include questionnaires, focus groups and interviews.
Stages of the study:
- Describe the magnitude of the problem
- Map the barriers to adherence with colonoscopy recommendations among patients, physicians and geographic availability of colonoscopies facilities.
- Suggest intervention models for physicians, patients and organisations according to the information provided by data collection.
- Recommendation to decision makers on the implementation of national policy intervention.
Data processing: will use SPSS statistical analysis with the types of variables.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| Completed followup | All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and had a colonoscopy following the result. | |
| Did not complete followup | All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and did not have a colonoscopy following the result. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables related to non-completion of colonoscopy following a positive fecal occult blood test
Quantitative and qualitative variables associated with non-completion of colonoscopical followup among members with a positive screening fecal occult test result: Availability and distance variables (hours, kms), Patient knowledge and awareness (questionnaire scores), Physician knowledge and awareness (qualitative data),
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completion20 Dec 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meuhedet. Healthcare Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Sponsor
- Investigators
- Revital Azulay, MSC, Principal investigator, Meuhedet Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534142
- Sponsor's protocol ID
- 01-20-05-15
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Is the patient activation measure associated with adherence to colonoscopy after a positive fecal occult blood test result? Isr J Health Policy Res. 2018 Dec 21;7(1):74. doi: 10.1186/s13584-018-0270-8.
PubMed 30577883
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence
- ClinicalTrials.gov ID
- NCT02534142
- Acronym / sponsor ID
- 01-20-05-15
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Meuhedet. Healthcare OrganizationUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 27 Aug 2015 (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.
Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Using both quantitative and qualitative methods, the investigators will identify organisational and personal barriers to completion of followup of positive FOBT.
Detailed description
Colorectal cancer is the second in incidence and mortality among malignant tumors. Early detection of the disease is an effective means of reducing mortality and is possible through a fecal occult blood test. In the case of a positive result colonoscopy is required. In Israel, about 30% of people with a positive occult blood test do not perform a follow-up test.
The aim of the study is to identify existing barriers to undergoing colonoscopy in a normal-risk population and improving adherence through different intervention mechanisms. At the end of the study we will describe effective intervention models at three levels: the patient, physicians and the organisation to improve early detection of colon cancer.
Innovation of the Study
- It will focus on the normal-risk population groups in Israel with a positive occult blood that didn't undergo colonoscopy.
- Will identify the barriers in diverse populations
- Will review the accessibility of diagnostic facilities forcolon cancer in Israel.
- Will propose intervention programs to improve adherence at all levels in the process.
Study Methods: A prospective study sing both both quantitative and qualitative methods in Meuhedet Health Services Target Population: Health system managers, physicians, and patients (a representative sample of 200 patients adhere colonoscopy and 600 that didn't adhere). Data collection databases from Meuhedet. The study will include questionnaires, focus groups and interviews.
Stages of the study:
- Describe the magnitude of the problem
- Map the barriers to adherence with colonoscopy recommendations among patients, physicians and geographic availability of colonoscopies facilities.
- Suggest intervention models for physicians, patients and organisations according to the information provided by data collection.
- Recommendation to decision makers on the implementation of national policy intervention.
Data processing: will use SPSS statistical analysis with the types of variables.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completed followup | – | –All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and had a colonoscopy following the result. |
| Did not complete followup | – | –All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and did not have a colonoscopy following the result. |
Who may qualify
- Ages
- 51 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a representative sample of Meuhedet members who adhered / did not adhere to followup of a positive fecal occult blood test using colonoscopy
Key inclusion criteria (1 listed)
- Members of MHC aged 50-74 who completed a fecal occult blood test during the study period.
Key exclusion criteria (1 listed)
- None
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
Variables related to non-completion of colonoscopy following a positive fecal occult blood test
Time frame: 18 months
Quantitative and qualitative variables associated with non-completion of colonoscopical followup among members with a positive screening fecal occult test result: Availability and distance variables (hours, kms), Patient knowledge and awareness (questionnaire scores), Physician knowledge and awareness (qualitative data),
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 22 Aug 2018.
- Derived from this study: PubMed 30577883Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Is the patient activation measure associated with adherence to colonoscopy after a positive fecal occult blood test result? Isr J Health Policy Res. 2018 Dec 21;7(1):74. doi: 10.1186/s13584-018-0270-8.
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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.
Revital Azulay, MSC principal investigator
Meuhedet Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Meuhedet. Healthcare Organization at 1 site in Israel.
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 22 Aug 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 Israel. 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?
Variables related to non-completion of colonoscopy following a positive fecal occult blood test (time frame: 18 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 NCT02534142, 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 22 Aug 2018.