Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01612338
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2012-06-01
Brief Title:
Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
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
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 academicpractice 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 academicpractice 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 YBCSs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None