Colorectal NeoplasmsNCT01688817
The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
A study testing Physician's counseling and Information leaflet in people with Colorectal Neoplasms, run by Maria Sklodowska-Curie National Research Institute of Oncology.
Trial summary
The purpose of this study is to assess the impact of physician's counseling on participation and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening program Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Physician's counseling and Information leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2010
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-65 years of age
Who cannot join
- colonoscopy within last 10 years
- change in bowel habits in the previous six months
- a visible blood in stool (unless related to known hemorrhoids)
- anemia or weight loss of unknown cause
- severe comorbid conditions making subject ineligible for screening colonoscopy
About this study
Official title: The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
The purpose of this study is to assess the impact of physician's counseling on participation and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening program
Read the detailed description
Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.
To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.
In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.
- Conditions
- Colorectal Neoplasms
- Being tested
- Physician's counseling, Information leaflet
- Keywords
- Colorectal Neoplasms, Colonoscopy, Early Detection of Cancer, Patient Selection, Patient Participation, Physicians, Primary Care, Conscious Sedation
- Medical subject headings
- Colorectal Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician's counselingOther
Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
Information leafletOther
Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
| Study group | Role | What they receive |
|---|---|---|
| Physician's counseling | Other | Not described Receives: Other: Physician's counseling |
| Information leaflet | Active comparator | Not described Receives: Other: Information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Measured: Six months after intervention
Secondary outcomes (1)
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Measured: Six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionMay 2010
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 NeoplasmsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Sponsor
- Investigators
- Jaroslaw Regula, MD, PhD, Study director, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of OncologyMichal F. Kaminski, MD, PhD, Study chair, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, PolandMichal Wiszniewski, MD, Principal investigator, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688817
- Sponsor's protocol ID
- CMKP-2008
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Boguradzka A, Wiszniewski M, Kaminski MF, Kraszewska E, Mazurczak-Pluta T, Rzewuska D, Ptasinski A, Regula J. The effect of primary care physician counseling on participation rate and use of sedation in colonoscopy-based colorectal cancer screening program--a randomized controlled study. Scand J Gastroenterol. 2014 Jul;49(7):878-84. doi: 10.3109/00365521.2014.913191. Epub 2014 May 5.
PubMed 24797871
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
- ClinicalTrials.gov ID
- NCT01688817
- Acronym / sponsor ID
- CMKP-2008
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Colonoscopy, Early Detection of Cancer, Patient Selection, Patient Participation, Physicians, Primary Care, Conscious Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Sep 2012 (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.
The purpose of this study is to assess the impact of physician's counseling on participation and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening program
Detailed description
Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.
To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.
In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician's counseling | Other | Other: Physician's counseling |
| Information leaflet | Active comparator | Other: Information leaflet |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-65 years of age
Key exclusion criteria (5 listed)
- colonoscopy within last 10 years
- change in bowel habits in the previous six months
- a visible blood in stool (unless related to known hemorrhoids)
- anemia or weight loss of unknown cause
- severe comorbid conditions making subject ineligible for screening colonoscopy
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 |
|---|---|---|
| Physician's counselingColorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them. | Other | Physician's counseling |
| Information leafletPatients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program. | Other | Information leaflet |
Primary outcome
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Time frame: Six months after intervention
1 secondary outcome
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Time frame: Six months after intervention
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 26 Sep 2012.
- Derived from this study: PubMed 24797871Boguradzka A, Wiszniewski M, Kaminski MF, Kraszewska E, Mazurczak-Pluta T, Rzewuska D, Ptasinski A, Regula J. The effect of primary care physician counseling on participation rate and use of sedation in colonoscopy-based colorectal cancer screening program--a randomized controlled study. Scand J Gastroenterol. 2014 Jul;49(7):878-84. doi: 10.3109/00365521.2014.913191. Epub 2014 May 5.
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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.
Jaroslaw Regula, MD, PhD study director
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Michal F. Kaminski, MD, PhD study chair
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Michal Wiszniewski, MD principal investigator
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Questions about this trial
What is this clinical trial studying?
A study testing Physician's counseling and Information leaflet in people with Colorectal Neoplasms, run by Maria Sklodowska-Curie National Research Institute of Oncology.
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 5 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 26 Sep 2012. 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?
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program (time frame: Six months after intervention). 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 NCT01688817, 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 26 Sep 2012.