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Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making (CARR2)

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ClinicalTrials.gov Identifier: NCT01558583
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colon Cancer Prostate Cancer Other: Rating and Ranking Task Other: Discrete Choice Task Other: Balance Sheet Task Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Rating and Ranking Group
A group of individuals from the United States and Australia who complete a rating and ranking task.
 Other: 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.
Discrete Choice Group
A group of individuals from the United States and Australia who complete a discrete choice experiment task.
 Other: Discrete Choice 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.
Balance Sheet Group
Individuals from the United States and Australia who will complete an implicit values clarification task
 Other: Balance Sheet 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Unlabeled screening test options [ Time Frame: 1 day ]
    choice on a single question among unlabeled screening test options


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558583


Locations
United States, North Carolina
Cecil G. Sheps Center for Health Services Research
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Michael Pignone, MD, MPH University of North Carolina, Chapel Hill
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01558583     History of Changes
Other Study ID Numbers: UCRF-CARR2-11-0861
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: July 2012

Keywords provided by University of North Carolina, Chapel Hill:
Colon
Prostate
Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Colorectal Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases