Evaluating Tools for Health Promotion and Disease Prevention

Breast Cancer Clinical Trial

Official title:

Evaluating Tools for Health Promotion and Disease Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164658
• Other study ID #: CDC-OGDP-4444
• Secondary ID: U36/CCU319276-MM
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: January 6, 2010
• Start date: September 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.

Description:

The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).

The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8400
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• member of participating primary care practice network

• able to provide informed consent

• able to complete data assessment tools in English

Exclusion Criteria:

• diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer

• currently pregnant

• evidence of cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes
• Myocardial Ischemia
• Ovarian Cancer
• Stroke

Intervention

Behavioral:
• Familial risk assessment and personalized prevention messages

Locations

Country	Name	City	State
United States	Great Lakes Research into Practice Network (GRIN)	Ann Arbor	Michigan
United States	Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices	Evanston	Illinois
United States	American Academy of Family Physicians National Research Network (AAFP-NRN).	Leawood	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	American Academy of Family Physicians National Research Network, Case Western Reserve University, Evanston Northwestern Healthcare Research Institute, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
Secondary	Primary care physicians' provision of preventive services in response to family medical history.