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Statewide Communication to Reach Diverse Low Income Women

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ClinicalTrials.gov Identifier: NCT02956681
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer Prevention Institute of California
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Syndrome Behavioral: Intervention Group Behavioral: Delayed Intervention Group Not Applicable

Detailed Description:

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 otherwise. Our study demonstrated that, for the complex and highly personal issue of HBOC, multiple attempts over a period of months are needed and justified.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Statewide Communication to Reach Diverse Low Income Women
Study Start Date : October 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2013


Arm Intervention/treatment
Active Comparator: Delayed Intervention Group
In this arm of the randomized delayed intervention control trial, participants randomized to delayed intervention control group were sent a brochure with information on hereditary breast and ovarian cancer and the phone number to call a cancer risk program for free genetic counseling.
Behavioral: Delayed Intervention Group
This is a randomized delayed intervention control trial in which eligible callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that they are eligible to speak to a genetic counselor who is available at no charge at SFGH and that they will be sent a brochure with information on where to call.

Active Comparator: Intervention Group
In this arm of the randomized delayed intervention control trial, those randomized to the intervention group were told that because of their family history, we were able to offer them a free genetic counseling appointment.
Behavioral: Intervention Group
Callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that a genetic counselor will call them back to offer them a free genetic counseling appointment and that a brochure will be sent. A UCSF/SFGH genetic counseling assistant will call them back within a few days to offer them a free genetic counseling appointment at SFGH.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Residence within one of six local counties (for ease of access to our sites offering free genetic counseling and testing), age 25+, and English- or Spanish-speaking (the languages in which genetic counseling was conducted at risk program sites).

Exclusion Criteria

  • American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander will not be included since very few call EWC.
  • Children (individuals under 25 years of age) will not be included in the study.
  • The rationale for this exclusion is that the research topic is not relevant to children.
  • The EWC does not target children, whose medical care is typically under the control of their parents or guardians.

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): NCT02956681


Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Cancer Prevention Institute of California
Investigators
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Principal Investigator: Rena J Pasick, DrPH University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02956681     History of Changes
Other Study ID Numbers: UCSF-SW-2007
R01CA129096 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases