Clinical trial NCT01575990: Elders Preferences in Care Decisions
Official title: Improving Appropriate Colorectal Cancer Screening in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Detection of Cancer
Colon Cancer
Decision Making
Patient-Centered Care
Keywords: Colon cancer screening
Decision support interventions
Health status
Patient-centered care
Age
Randomized controlled trial
Double blind
UNC
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-04-12
Enrollment: 424
Sex: ALL
Minimum age (years): 70
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Appropriate colorectal cancer screening
timeFrame: Six months after intervention or control was adminstered
Secondary outcomes:
measure: Appropriate colorectal cancer screening decisions
timeFrame: At baseline (after intervention or control was administered)
measure: Appropriate screening and mediators
timeFrame: Six months after intervention or control was adminstered
measure: Appropriate screening for health strata
timeFrame: Six months after intervention or control was adminstered
measure: Appropriate screening for stool cards
timeFrame: Six months after intervention or control was adminstered
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Practiced Based Research Network
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Carmen L Lewis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Rowena J Dolor, MD, MHS
role: STUDY_DIRECTOR
References:
citation: 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.