Clinical Trial: Statewide Communication to Reach Diverse Low Income Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Statewide Communication to Reach Diverse Low Income Women

Brief Summary: Recruitment for prevention, and early detection among health disparities populations represents a major challenge in chronic disease control. This effect is magnified for individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis. Costs are typically high, particularly given the common practice of developing a single outreach channel to address each disease or condition. In a randomized delayed intervention control trial, the investigators tested a strategy to identify low-income women at high risk for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them to free genetic counseling.

Detailed Summary:

This study addresses a disparity in services related to the rare but serious condition of HBOC. In a randomized delayed intervention control trial, the investigators were able to identify high-risk but predominantly unaffected women among callers seeking referrals to free cancer screening. The investigators compared an immediate offer of a genetic counseling appointment to information on hereditary breast and ovarian cancer sent by mail. Our study demonstrated that when a diverse population of low-income women calls a trusted information and referral source, it is possible to both engage them on a topic that is different from the purpose for their call and to recruit them for participation in research.

Our intervention was designed to fit as seamlessly as possible with two end user organizations. Existing staff (Information Specialists) of the state's phone service administered a simple family history screener similar to their usual procedure for assessing eligibility for free mammography. Cancer Risk Program Genetic Counseling Assistants followed up with an outcall, just as they do normally in response to family history screeners filled out in the hospital's mammography clinic. Our results not only showed a significantly larger effect on use of genetic counseling with the call and appointment offer compared with a mailed brochure, it was clear from calls made to women in both arms after the intervention period that calling is not only effective but essential to encourage use of genetic counseling in this population. The number of women counseled in the intervention group was initially much higher than the control group, and additional intervention group members obtained counseling when called again after the two month intervention period. The addition of genetic counseling by phone enabled a substantial number of women to obtain counseling who would not have done so othe
Sponsor: University of California, San Francisco

Current Primary Outcome: Receipt of Genetic Counseling During Intervention Period [ Time Frame: Up to three years ]

The primary outcome measure is receipt of genetic counseling within the two month intervention period.


Original Primary Outcome: Same as current

Current Secondary Outcome: Time to Counseling [ Time Frame: Up to three years ]

The study arms were compared with respect to time from randomization to counseling appointment using the log-rank test, and Kaplan-Meier curves were computed for each study arm.


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: May 17, 2016
Date Started: October 2007
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016