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

Interventions to Increase Screening Utilization by Breast Cancer Survivors and Their High Risk Female Relatives: Using Cancer Surveillance and the Michigan Genomics Academic-Practice Partnership

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01612338
Enrollment
1290
Registered
2012-06-05
Start date
2012-07-31
Completion date
2014-09-30
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Cancer in Women With a Strong Family History, Breast Cancer in Young Women

Keywords

breast cancer, young age of onset, family history, screening interventions, family support

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.

Interventions

BEHAVIORALTargeted

Targeted letter and booklet

BEHAVIORALEnhanced Tailored

Tailored letter and booklet, enhanced family communication and support brochure

Sponsors

Michigan Department of Community Health
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
breast cancer screening9 monthsself report of mammogram and clinical breast exam
genetic counseling9 monthsself report of obtaining genetic counseling

Secondary

MeasureTime frameDescription
barriers to screening9 monthsBarriers and Facilitators to Mammography
knowledge of breast cancer genetics9 monthsGenetic literacy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026