Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making - Full Text View

Purpose

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	Intervention
Colorectal Cancer Colon Cancer Prostate Cancer	Other: Rating and Ranking Task Other: Discrete Choice Task Other: Balance Sheet Task


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Cancer Colorectal Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Participant-reported most important attribute from survey [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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:

Participant-reported intent to undergo screening from survey [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the number of participants who state they plan to be screened for condition
Unlabeled screening test options [ Time Frame: 1 day ] [ Designated as safety issue: No ]
choice on a single question among unlabeled screening test options


Enrollment:	1831
Study Start Date:	July 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

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.


Responsible Party:	Michael Pignone, MD, MPH, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01558583 History of Changes
Other Study ID Numbers:	UCRF-CARR2-11-0861
Study First Received:	February 7, 2012
Last Updated:	July 9, 2012
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016

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