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Early Detection of CancerEPIC-DNCT01575990

Elders Preferences in Care Decisions

A study testing Making A Decision About CRC Screening and Drivers 65 Plus in people with Early Detection of Cancer and Colon Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit. Read more about this study

Who is it for?
Ages 70 to 84 yearsHealthy volunteers can take part
What is being tested?
Making A Decision About CRC Screening and Drivers 65 Plus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
424 participants
Where
1 siteUnited States
Study dates
Mar 2012to Feb 2015
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 70 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Men and women ages 70 to 84
  • Not up to date with colon cancer screening or surveillance

Who cannot join

  • Men and women younger than 70 years of age or older than 84
  • History of Colorectal Cancer
  • Inflammatory bowel disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Practiced Based Research Network

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Improving Appropriate Colorectal Cancer Screening in Elderly Patients

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

Read the detailed description

The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.

Being tested
Making A Decision About CRC Screening, Drivers 65 Plus
Keywords
Colon cancer screening, Decision support interventions, Health status, Patient-centered care, Age, Randomized controlled trial, Double blind, UNC
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Making A Decision About CRC ScreeningBehavioural

    Also called Making A Decision About Colon Cancer Screening Woman 70, Making A Decision About Colon Cancer Screening Woman 75, Making A Decision About Colon Cancer Screening Woman 80, Making A Decision About Colon Cancer Screening Men 70

    Targeted by age and gender with 3 components.

    1. Educational component
    2. Values clarification exercise
    3. Individualized decision making worksheet

    The intervention or control condition is administered before the index visit with the patient's provider.

  • Drivers 65 PlusBehavioural

    Also called Attention control, Control condition

    This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.

Study groups in NCT01575990
Study groupRoleWhat they receive
Making A Decision About CRC ScreeningExperimentalA decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.
Receives: Behavioral: Making A Decision About CRC Screening
Drivers 65 PlusPlacebo comparatorThe placebo comparator is an attention control with information about driving tips for drivers age 65 and older.
Receives: Behavioral: Drivers 65 Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appropriate colorectal cancer screening

    The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

    Measured: Six months after intervention or control was adminstered

Secondary outcomes (4)

  1. Appropriate colorectal cancer screening decisions

    The proportion of participants classified as having appropriate colorectal cancer screening decisions in the intervention group will be compared to the control group. Appropriate screening decision making is a combined outcome measure using patient report of intent to complete or not complete CRC screening tests and discussions about CRC screening with their provider. This outcome will be measured immediately after the patient and provider index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

    Measured: At baseline (after intervention or control was administered)

  2. Appropriate screening and mediators

    For the mediation analysis covariates will be evaluated as potential mediators. The potential mediators to be examined include adequate preparation for individualized decision making (adequate knowledge+ clear values); knowledge scores, screening preference before the index visit, decisional balance, reported discussion during the index visit, gender, previous screening, functional status, and literacy level.

    Measured: Six months after intervention or control was adminstered

  3. Appropriate screening for health strata

    Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating exploratory analyses to examine effect of the intervention in sub-groups of patients. We will examine the effect in the three strata (best, intermediate, worst health groups) defined by age and Charlson comorbidity score.

    Measured: Six months after intervention or control was adminstered

  4. Appropriate screening for stool cards

    For this analysis, appropriate screening test completion will include stool cards for all age groups and health groups. Analyses described for the primary outcome will be performed using this classification of appropriate screening test completion.

    Measured: Six months after intervention or control was adminstered

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01575990
Sponsor's protocol ID
11-1638
Other IDs
P01HS021133-01
Acronym
EPIC-D
Status last verified
May 2015
First submitted
29 Mar 2012
Last updated
10 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • Dalton AF, Golin CE, Morris C, Kistler CE, Dolor RJ, Bertin KB, Suresh K, Patel SG, Lewis CL. Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244982. doi: 10.1001/jamanetworkopen.2022.44982.

    PubMed 36469317

  • Lewis CL, Kistler CE, Dalton AF, Morris C, Ferrari R, Barclay C, Brewer NT, Dolor R, Harris R, Vu M, Golin CE. A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial. Med Decis Making. 2018 Jul;38(5):614-624. doi: 10.1177/0272989X18773713.

    PubMed 29847251

Questions about this trial

What is this clinical trial studying?

A study testing Making A Decision About CRC Screening and Drivers 65 Plus in people with Early Detection of 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 2 inclusion and 3 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 10 Jan 2022. 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. Some participants in this study may receive a placebo. 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?

Appropriate colorectal cancer screening (time frame: Six months after intervention or control was adminstered). 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 NCT01575990, which also lists 2 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 10 Jan 2022.

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