Trial record 6 of 287 for:    colorectal cancer AND (women OR woman OR female)

Elders Preferences in Care Decisions (EPIC-D)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Duke University
Information provided by (Responsible Party):
Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01575990
First received: March 29, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Early Detection of Cancer
Colon Cancer
Decision Making
Patient-Centered Care
Behavioral: Making A Decision About CRC Screening
Behavioral: Drivers 65 Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Appropriate Colorectal Cancer Screening in Elderly Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Appropriate colorectal cancer screening [ Time Frame: Six months after intervention or control was adminstered ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Appropriate colorectal cancer screening decisions [ Time Frame: At baseline (after intervention or control was administered) ] [ Designated as safety issue: No ]
    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.

  • Appropriate screening and mediators [ Time Frame: Six months after intervention or control was adminstered ] [ Designated as safety issue: No ]
    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.

  • Appropriate screening for health strata [ Time Frame: Six months after intervention or control was adminstered ] [ Designated as safety issue: No ]
    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.

  • Appropriate screening for stool cards [ Time Frame: Six months after intervention or control was adminstered ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Making A Decision About CRC Screening
A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.
Behavioral: Making A Decision About CRC Screening

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.

Other Names:
  • 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
  • Making A Decision About Colon Cancer Screening Men 75
  • Making A Decision About Colon Cancer Screening Men 80
Placebo Comparator: Drivers 65 Plus
The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.
Behavioral: Drivers 65 Plus
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.
Other Names:
  • Attention control
  • Control condition

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

Ages Eligible for Study:   70 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01575990

Locations
United States, North Carolina
Duke Practiced Based Research Network
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
Investigators
Principal Investigator: Carmen L Lewis, MD, MPH University of North Carolina
Study Director: Rowena J Dolor, MD, MHS Duke University
  More Information

No publications provided

Responsible Party: Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01575990     History of Changes
Other Study ID Numbers: 11-1638, PO1 HS 21133-01
Study First Received: March 29, 2012
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Colon cancer screening
Decision support interventions
Health status
Patient-centered care
Age
Randomized controlled trial
Double blind
UNC

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 10, 2014