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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Michigan Department of Community Health
Information provided by (Responsible Party):
Maria Katapodi, PhD, RN, University of Michigan
ClinicalTrials.gov Identifier:
NCT01612338
First received: June 1, 2012
Last updated: February 10, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Breast Cancer in Young Women
Breast Cancer in Women With a Strong Family History
Behavioral: Targeted
Behavioral: Enhanced Tailored

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • breast cancer screening [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    self report of mammogram and clinical breast exam

  • genetic counseling [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    self report of obtaining genetic counseling


Secondary Outcome Measures:
  • barriers to screening [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Barriers and Facilitators to Mammography

  • knowledge of breast cancer genetics [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 9000
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targeted
Targeted letter and booklet
Behavioral: Targeted
Targeted letter and booklet
Experimental: Tailored
Tailored letter and booklet, enhanced family communication and support brochure
Behavioral: Enhanced Tailored
Tailored letter and booklet, enhanced family communication and support brochure

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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612338

Contacts
Contact: Maria C. Katapodi, PhD 734-647-0178 mkatapo@umich.edu

Locations
United States, Michigan
University of Michigan School of Nursing Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Maria C. Katapodi, PhD    734-647-0178    mkatapo@umich.edu   
Contact: Kari Mendelsohn-Victor, MPH    734-615-4017    karimend@umich.edu   
Principal Investigator: Maria C. Katapodi, PhD         
Principal Investigator: Maria C Katapodi, PhD         
Michigan Department of Community Health Recruiting
Lansing, Michigan, United States, 48913
Contact: Deb Duquette, CGC    517-335-8286    duquetted@michigan.gov   
Contact: Beth Anderson, MPH    517-335-9785    AndersonB@michigan.gov   
Sponsors and Collaborators
University of Michigan
Michigan Department of Community Health
Investigators
Principal Investigator: Maria C. Katapodi, PhD University of Michigan School of Nursing
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Katapodi, PhD, RN, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01612338     History of Changes
Other Study ID Numbers: 5U48DP001901-03
Study First Received: June 1, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
breast cancer
young age of onset
family history
screening interventions
family support

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014