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Impact of Family History and Decision Support on High-risk Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247336
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : August 19, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Family health history platform (MeTree) Not Applicable

Detailed Description:
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Family History and Decision Support on High-risk Cancer Screening
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 13, 2020
Actual Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Experimental: Immediate
Patients will complete a family health history platform at enrollment
Behavioral: Family health history platform (MeTree)
Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree

Active Comparator: Delayed
Patients will complete a family health history platform 12 months following enrollment
Behavioral: Family health history platform (MeTree)
Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree




Primary Outcome Measures :
  1. Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening [ Time Frame: 12 months ]
    Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.


Secondary Outcome Measures :
  1. Number of Participants Who Received Recommended Colorectal Cancer Screening [ Time Frame: 12 months ]
    Among patients who received a referral, the percentage who received recommended colorectal cancer screening.

  2. Number of Patients Who Received Referral for Genetic Consultation [ Time Frame: 12 months ]
    Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Primary care provider inclusion criteria:

  • primary care physician,
  • physician assistant, or nurse practitioner;
  • at least one half-day of primary care clinic per week.

Patient inclusion criteria:

  • assigned to an enrolled PCP;
  • English as preferred language;
  • no plans to relocate or leave the VA system in the next 12 months;
  • at least one primary care appointment in the 18 months prior to enrollment;
  • upcoming PCP appointment with assigned PCP;
  • aged 40-64 years; no previous history of colorectal cancer or adenomatous polyps or inflammatory bowel disease;
  • no endoscopy within previous 3 years; some knowledge of family health history

Exclusion Criteria:

n/a (contained within inclusion criteria)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247336


Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Corrine I. Voils, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] September 4, 2018

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02247336    
Other Study ID Numbers: IIR 12-378
First Posted: September 25, 2014    Key Record Dates
Results First Posted: August 19, 2021
Last Update Posted: September 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
colorectal cancer
early detection of cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases