Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives

Not Applicable

Completed

• Conditions: Breast Cancer in Women With a Strong Family History; Breast Cancer; Breast Cancer in Young Women
• Interventions: Behavioral: Targeted; Behavioral: Enhanced Tailored

• Registration Number: NCT01612338
• Lead Sponsor: University of Michigan

Brief Summary

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening for young breast cancer survivors and their cancer-free, female relatives at greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 20-45 years regarding their breast cancer screening utilization; 2) identify and survey the survivors' female relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. A follow-up survey will assess the effectiveness of each intervention on a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention.

Detailed Description

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) propose a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening utilization for young breast cancer survivors (YBCS), and their cancer-free, female relatives at greatest risk for breast cancer (high-risk relatives). The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 25-45 years regarding their breast cancer screening utilization; 2) identify and survey YBCS' high-risk relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. Aim 1, will be accomplished in year 1 by MDCH, UM and MCSP. Following approval by appropriate review boards (MDCH, UM, and MCSP), reporting facilities and physicians of record, 3000 YBCS will be mailed a request to participate in the project and a baseline survey. The baseline survey will obtain information on the YBCS's: a) willingness to participate; b) current breast cancer screening utilization; c) perceived barriers and facilitators to screening and other outcomes related to breast cancer screening; d) identification of high-risk relatives to participate in the study and interest in serving as an advocate for their high-risk relatives to participate. Aim 2, will be accomplished in year 2 by the UM and MDCH. Based on the information provided by YBCS, the MDCH will identify up to two high-risk relatives per YBCS. UM and MDCH will mail YBCS who agree to participate in the study baseline surveys to distribute to their selected high-risk relatives. The baseline survey to high-risk relatives will obtain information on their: a) willingness to participate in the project; b) current breast cancer screening utilization; and c) perceived barriers and facilitators to screening and other outcomes related to breast cancer screening. Aim 3, will be accomplished by UM and MDCH. YBCS and their high-risk relatives will be randomized (as a family unit) to receive two versions of a small media, evidence-based intervention aiming to increase appropriate utilization of breast cancer screening services and other outcomes. In year 2-3, 9 months after YBCS and high-risk female relatives receive the intervention, UM will mail a follow-up survey to YBCS and their high-risk relatives to evaluate the effectiveness of each intervention version on: a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention. The State of Michigan is considered a national leader in cancer prevention, control, and public health genomics. Key partners have significant prior experience in conducting studies with cancer survivors and their high-risk relatives. This project would greatly enhance state efforts in cancer prevention and control.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-05
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1290

Inclusion Criteria

• For breast cancer survivors

  • Female
  • 20-64 years of age
  • Being diagnosed with invasive breast cancer between 20 and 45 years of age
  • Being diagnosed with DCIS between 20 and 45 years of age
  • Michigan resident at time of diagnosis
  • able to read and understand English
  • not currently pregnant, incarcerated, or institutionalized

• For high risk relatives

  • Female
  • First- or second- degree relatives of survivor
  • 25-64 years of age
  • US resident
  • Able to read and understand English
  • Unaffected with any type of cancer
  • Not currently pregnant, incarcerated, or institutionalized
  • Survivor is willing to contact

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted	Targeted	Targeted letter and booklet
Tailored	Enhanced Tailored	Tailored letter and booklet, enhanced family communication and support brochure

Primary Outcome Measures

Name	Time	Method
breast cancer screening	9 months	self report of mammogram and clinical breast exam
genetic counseling	9 months	self report of obtaining genetic counseling

Secondary Outcome Measures

Name	Time	Method
barriers to screening	9 months	Barriers and Facilitators to Mammography
knowledge of breast cancer genetics	9 months	Genetic literacy

Trial Locations

Locations (2)

University of Michigan School of Nursing; 🇺🇸 Ann Arbor, Michigan, United States

Michigan Department of Community Health; 🇺🇸 Lansing, Michigan, United States