Colorectal CancerCARR2NCT01558583
Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making
A study testing Rating and Ranking Task, Discrete Choice Task and Balance Sheet Task in people with Colorectal Cancer and Colon Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… 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, Colon Cancer, Prostate Cancer
- What is being tested?
- Rating and Ranking Task, Discrete Choice Task and Balance Sheet Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,831 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2011
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cecil G. Sheps Center for Health Services Research
Chapel Hill, North Carolina, 27599
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Colon Cancer, Prostate Cancer
- Being tested
- Rating and Ranking Task, Discrete Choice Task, Balance Sheet Task
- Keywords
- Colon, Prostate, Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rating and Ranking TaskOther
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 TaskOther
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 TaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rating and Ranking Group | Other | A group of individuals from the United States and Australia who complete a rating and ranking task. Receives: 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. Receives: Other: Discrete Choice Task |
| Balance Sheet Group | Other | Individuals from the United States and Australia who will complete an implicit values clarification task Receives: Other: Balance Sheet Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
Participant-reported intent to undergo screening from survey
the number of participants who state they plan to be screened for condition
Measured: 1 day
Unlabeled screening test options
choice on a single question among unlabeled screening test options
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Pignone, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558583
- Sponsor's protocol ID
- UCRF-CARR2-11-0861
- Acronym
- CARR2
- Status last verified
- Jul 2012
- First submitted
- 7 Feb 2012
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24272830Howard 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.
PubMed 24093428Pignone 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.
PubMed 23400279
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01558583
- Acronym / sponsor ID
- CARR2 / UCRF-CARR2-11-0861
- Conditions
- Colorectal Cancer, Colon Cancer, Prostate Cancer
- Keywords
- Colon, Prostate, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,831 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Mar 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.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rating and Ranking Group | Other | Other: Rating and Ranking TaskA group of individuals from the United States and Australia who complete a rating and ranking task. |
| Discrete Choice Group | Other | Other: Discrete Choice TaskA group of individuals from the United States and Australia who complete a discrete choice experiment task. |
| Balance Sheet Group | Other | Other: Balance Sheet TaskIndividuals from the United States and Australia who will complete an implicit values clarification task |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Colorectal cancer
- Prostate cancer screening
Key exclusion criteria (4 listed)
- Colorectal Cancer
- Prostate cancer
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 |
|---|---|---|
| Rating and Ranking TaskIndividuals 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 | Rating and Ranking Group |
| Discrete Choice TaskIndividuals 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 | Discrete Choice Group |
| Balance Sheet TaskIndividuals 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. | Other | Balance Sheet Group |
Primary outcome
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.
2 secondary outcomes
Participant-reported intent to undergo screening from survey
Time frame: 1 day
Unlabeled screening test options
Time frame: 1 day
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 25 Apr 2017.
- Derived from this study: PubMed 24272830Brenner 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.
- Derived from this study: PubMed 24093428Howard 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.
- Derived from this study: PubMed 23400279Pignone 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.
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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.
Michael Pignone, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rating and Ranking Task, Discrete Choice Task and Balance Sheet Task in people with Colorectal Cancer and Colon Cancer, run by University of North Carolina, Chapel Hill at 1 site 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 4 inclusion and 4 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Participant-reported most important attribute from survey (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01558583, which also lists 3 linked publications.
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 25 Apr 2017.