Colorectal Cancer ScreeningNCT01534923
Doctor-Patient Communication About Colorectal Cancer Screening
An observational study of Colorectal Cancer Screening, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2012to 26 Dec 2019
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Five health centers of the NYC RING will participate in this project. All are located in underserved urban communities within the Bronx.
Who may be able to join
- Physicians
- Attending physicians or third year residents specializing in internal medicine or family medicine, as per the medical director from the clinic.
- Clinic is based at a NYC RING-affiliated practice.
- English speaking; Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.
- Patients
- Ages 50-75 years old, per the United States Preventive Services Task Force recommendations for screening. This will be determined by a pre-screening of medical records by the RSA.
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- Due for colorectal cancer screening at the time of the visit, ascertained through patient self-report (e.g., no colonoscopy within the past 10 years, no flexible sigmoidoscopy or barium enema within the past five years, and no FOBT within the past year).
- Coming for either an annual physical exam or chronic care follow up visit, per patient self-report.
- Planning to consult with the physician in English, per patient self-report. Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.
Who cannot join
- History of colorectal cancer, per patient self-report or per EMR..
- History of polyps being removed, per patient self-report.
- Colonoscopy scheduled in EMR at time of screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albert Einstein College of Medicine
The Bronx, New York
Hhc, Gun Hill and Tremont
The Bronx, New York
About this study
The purpose of this study is to learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient.
- Conditions
- Colorectal Cancer Screening
- Being tested
- surveys
- Keywords
- Doctor-Patient Communication, questionnaire, survey, 12-017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveysBehavioural
The intervention will be the audio-recording of the physician-patient consultation, patient and doctor surveys. These audio recordings will be coded. It will also include follow-up phone calls with patients.
| Study group | Role | What they receive |
|---|---|---|
| Pts having colorectal cancer screening | The target sample of this study will be approximately 200 primary care physician-patient consultations who discuss CRC screening during the course of a clinical visit. Physician and patient participants will come from primary care practices associated with the New York City Research and Improvement Networking Group (NYC RING). Receives: Behavioral: surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
describe doctor-patient communication about CRC screening
screening adherence through self report. Screening adherence will be assessed by contacting the patients and asking them if they received the CRC screening test their doctor ordered at the audio recorded visit.
Measured: 2 years
Secondary outcomes (2)
quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes.
Measured: 2 years
examine the association between the quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes
intent to be screened (immediately after the consultation) using the item from Geller et al.25 and 2) self-efficacy for screening (immediately after consultation) in case there are few events of actual screening.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study start7 Feb 2012
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, HHC, Gun HIll and Tremont, NYC RING, Director, Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534923
- Sponsor's protocol ID
- 12-017
- Status last verified
- Dec 2019
- First submitted
- 10 Feb 2012
- Last updated
- 2 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctor-Patient Communication About Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT01534923
- Acronym / sponsor ID
- 12-017
- Conditions
- Colorectal Cancer Screening
- Keywords
- Doctor-Patient Communication, questionnaire, survey, 12-017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, HHC, Gun HIll and Tremont, NYC RING, Director, Virginia Commonwealth University
- Study start
- 7 Feb 2012 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 17 Feb 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 learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts having colorectal cancer screening | – | Behavioral: surveysThe target sample of this study will be approximately 200 primary care physician-patient consultations who discuss CRC screening during the course of a clinical visit. Physician and patient participants will come from primary care practices associated with the New York City Research and Improvement Networking Group (NYC RING). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Five health centers of the NYC RING will participate in this project. All are located in underserved urban communities within the Bronx.
Key inclusion criteria (9 listed)
- Physicians
- Attending physicians or third year residents specializing in internal medicine or family medicine, as per the medical director from the clinic.
- Clinic is based at a NYC RING-affiliated practice.
- English speaking; Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.
- Patients
Key exclusion criteria (3 listed)
- History of colorectal cancer, per patient self-report or per EMR..
- History of polyps being removed, per patient self-report.
- Colonoscopy scheduled in EMR at time of screening.
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 |
|---|---|---|
| surveysThe intervention will be the audio-recording of the physician-patient consultation, patient and doctor surveys. These audio recordings will be coded. It will also include follow-up phone calls with patients. | Behavioural | Pts having colorectal cancer screening |
Primary outcome
describe doctor-patient communication about CRC screening
Time frame: 2 years
screening adherence through self report. Screening adherence will be assessed by contacting the patients and asking them if they received the CRC screening test their doctor ordered at the audio recorded visit.
2 secondary outcomes
quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes.
Time frame: 2 years
examine the association between the quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes
Time frame: 2 years
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 2 Jan 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites 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 Screening, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 9 inclusion and 3 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
describe doctor-patient communication about CRC screening (time frame: 2 years). 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 2 Jan 2020.