- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01558583
Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making (CARR2)
April 21, 2017 updated by: University of North Carolina, Chapel Hill
A Comparison of the Effect of a Conjoint Analysis Based Values Clarification Exercise, Rating and Ranking Exercise, and Balance Sheet for Colorectal Cancer Screening and Prostate Cancer Screening Decision Making
Participants will be recruited from the United States and Australia to take an online survey about colon cancer screening or prostate cancer screening.
Individuals selected for both the prostate cancer survey and the colon cancer study will be randomized to take one of three survey types - balance sheet, rating and ranking or conjoint analysis.
These surveys will help participants clarify their values and opinions about screening options for colon cancer or prostate cancer.
Participants' responses to the online survey are measured at one point in time - the time at which the participant takes the survey.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will compare effect of a conjoint analysis based values clarification exercise, ranking and rating, and a balance sheet on screening test preferences for colorectal cancer screening and prostate cancer screening using online surveys.
Recruitment will be conducted through Survey Sampling International (SSI), an online survey research firm.
Participants will be randomized to one of three arms to take online surveys.
Patients will complete either a conjoint analysis task, in which they will be asked to make a series of choices between hypothetical screening testing strategies with different attributes; a rating and ranking task for these same attributes; or they will make a choice after viewing a balance sheet of attributes.
Study Type
Interventional
Enrollment (Actual)
1831
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Cecil G. Sheps Center for Health Services Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Colorectal cancer
- men and women, ages 50-75, who can speak and read English.
Prostate cancer screening
- men, ages 50-75, who can speak and read English.
Exclusion Criteria:
Colorectal Cancer
- individuals with a previous personal or family history of colon cancer, personal history of polyps, or inflammatory bowel disease will be excluded.
Prostate cancer
- individuals with a previous personal or family history of prostate cancer will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Rating and Ranking Group
A group of individuals from the United States and Australia who complete a rating and ranking task.
|
Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a rating and ranking format.
The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
|
|
Other: Discrete Choice Group
A group of individuals from the United States and Australia who complete a discrete choice experiment task.
|
Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a discrete choice format.
The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
|
|
Other: Balance Sheet Group
Individuals from the United States and Australia who will complete an implicit values clarification task
|
Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a balance sheet format.
The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant-reported most important attribute from survey
Time Frame: 1 day
|
The single most important colon cancer or prostate cancer screening attribute indicated by the participant surveys.
Each participant will be randomly assigned to take one of three survey versions: either (1) a conjoint analysis task wherein they will be asked to make a series of choices between hypothetical screening testing strategies with different attributes; (2) a rating and ranking task for these same attributes; or (3) they will make a choice after viewing a balance sheet of attributes.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant-reported intent to undergo screening from survey
Time Frame: 1 day
|
the number of participants who state they plan to be screened for condition
|
1 day
|
|
Unlabeled screening test options
Time Frame: 1 day
|
choice on a single question among unlabeled screening test options
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Pignone, MD, MPH, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brenner A, Howard K, Lewis C, Sheridan S, Crutchfield T, Hawley S, Reuland D, Kistler C, Pignone M. Comparing 3 values clarification methods for colorectal cancer screening decision-making: a randomized trial in the US and Australia. J Gen Intern Med. 2014 Mar;29(3):507-13. doi: 10.1007/s11606-013-2701-0. Epub 2013 Nov 23.
- Howard K, Brenner AT, Lewis C, Sheridan S, Crutchfield T, Hawley S, Nielsen ME, Pignone MP. A comparison of US and Australian men's values and preferences for PSA screening. BMC Health Serv Res. 2013 Oct 5;13:388. doi: 10.1186/1472-6963-13-388.
- Pignone MP, Howard K, Brenner AT, Crutchfield TM, Hawley ST, Lewis CL, Sheridan SL. Comparing 3 techniques for eliciting patient values for decision making about prostate-specific antigen screening: a randomized controlled trial. JAMA Intern Med. 2013 Mar 11;173(5):362-8. doi: 10.1001/jamainternmed.2013.2651.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
March 19, 2012
First Posted (Estimate)
March 20, 2012
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Prostatic Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Prostatic Neoplasms
- Colorectal Neoplasms
Other Study ID Numbers
- UCRF-CARR2-11-0861
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.