NCT01558583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,831

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
Last Updated

April 25, 2017

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

February 7, 2012

Last Update Submit

April 21, 2017

Conditions

Keywords

ColonProstateCancer

Outcome Measures

Primary Outcomes (1)

  • Participant-reported most important attribute from survey

    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 Outcomes (2)

  • Participant-reported intent to undergo screening from survey

    1 day

  • Unlabeled screening test options

    1 day

Study Arms (3)

Rating and Ranking Group

OTHER

A group of individuals from the United States and Australia who complete a rating and ranking task.

Other: Rating and Ranking Task

Discrete Choice Group

OTHER

A group of individuals from the United States and Australia who complete a discrete choice experiment task.

Other: Discrete Choice Task

Balance Sheet Group

OTHER

Individuals from the United States and Australia who will complete an implicit values clarification task

Other: Balance Sheet Task

Interventions

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.

Rating and Ranking Group

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.

Discrete Choice Group

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.

Balance Sheet Group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cecil G. Sheps Center for Health Services Research

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsProstatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael Pignone, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 20, 2012

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 25, 2017

Record last verified: 2012-07

Locations