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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family health history platform (MeTree)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, early detection of cancer

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Durham VA Medical Center, Durham, NC
  • William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate

Delayed

Arm Description

Patients will complete a family health history platform at enrollment

Patients will complete a family health history platform 12 months following enrollment

Outcomes

Primary Outcome Measures

Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.

Secondary Outcome Measures

Number of Participants Who Received Recommended Colorectal Cancer Screening
Among patients who received a referral, the percentage who received recommended colorectal cancer screening.
Number of Patients Who Received Referral for Genetic Consultation
Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.

Full Information

First Posted
September 18, 2014
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02247336
Brief Title
Impact of Family History and Decision Support on High-risk Cancer Screening
Official Title
Impact of Family History and Decision Support on High-risk Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, early detection of cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
Patients will complete a family health history platform at enrollment
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
Patients will complete a family health history platform 12 months following enrollment
Intervention Type
Behavioral
Intervention Name(s)
Family health history platform (MeTree)
Intervention Description
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 Measure Information:
Title
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Description
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants Who Received Recommended Colorectal Cancer Screening
Description
Among patients who received a referral, the percentage who received recommended colorectal cancer screening.
Time Frame
12 months
Title
Number of Patients Who Received Referral for Genetic Consultation
Description
Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine I. Voils, PhD
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital, Madison, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2254
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31590688
Citation
Goldstein KM, Fisher DA, Wu RR, Orlando LA, Coffman CJ, Grubber JM, Rakhra-Burris T, Wang V, Scheuner MT, Sperber N, Datta SK, Nelson RE, Strawbridge E, Provenzale D, Hauser ER, Voils CI. An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial. Trials. 2019 Oct 7;20(1):576. doi: 10.1186/s13063-019-3659-y.
Results Reference
result
PubMed Identifier
36307642
Citation
Voils CI, Coffman CJ, Wu RR, Grubber JM, Fisher DA, Strawbridge EM, Sperber N, Wang V, Scheuner MT, Provenzale D, Nelson RE, Hauser E, Orlando LA, Goldstein KM. A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer. J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28.
Results Reference
derived

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

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