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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted
Enhanced Tailored
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, young age of onset, family history, screening interventions, family support

Eligibility Criteria

20 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • University of Michigan School of Nursing
  • Michigan Department of Community Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Targeted

Tailored

Arm Description

Targeted letter and booklet

Tailored letter and booklet, enhanced family communication and support brochure

Outcomes

Primary Outcome Measures

breast cancer screening
self report of mammogram and clinical breast exam
genetic counseling
self report of obtaining genetic counseling

Secondary Outcome Measures

barriers to screening
Barriers and Facilitators to Mammography
knowledge of breast cancer genetics
Genetic literacy

Full Information

First Posted
June 1, 2012
Last Updated
August 20, 2019
Sponsor
University of Michigan
Collaborators
Michigan Department of Community Health
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1. Study Identification

Unique Protocol Identification Number
NCT01612338
Brief Title
Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Michigan Department of Community Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer in Young Women, Breast Cancer in Women With a Strong Family History
Keywords
breast cancer, young age of onset, family history, screening interventions, family support

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted
Arm Type
Experimental
Arm Description
Targeted letter and booklet
Arm Title
Tailored
Arm Type
Experimental
Arm Description
Tailored letter and booklet, enhanced family communication and support brochure
Intervention Type
Behavioral
Intervention Name(s)
Targeted
Intervention Description
Targeted letter and booklet
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Tailored
Intervention Description
Tailored letter and booklet, enhanced family communication and support brochure
Primary Outcome Measure Information:
Title
breast cancer screening
Description
self report of mammogram and clinical breast exam
Time Frame
9 months
Title
genetic counseling
Description
self report of obtaining genetic counseling
Time Frame
9 months
Secondary Outcome Measure Information:
Title
barriers to screening
Description
Barriers and Facilitators to Mammography
Time Frame
9 months
Title
knowledge of breast cancer genetics
Description
Genetic literacy
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C. Katapodi, PhD
Organizational Affiliation
University of Michigan School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Nursing
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Department of Community Health
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48913
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23448100
Citation
Katapodi MC, Northouse LL, Schafenacker AM, Duquette D, Duffy SA, Ronis DL, Anderson B, Janz NK, McLosky J, Milliron KJ, Merajver SD, Duong LM, Copeland G. Using a state cancer registry to recruit young breast cancer survivors and high-risk relatives: protocol of a randomized trial testing the efficacy of a targeted versus a tailored intervention to increase breast cancer screening. BMC Cancer. 2013 Mar 1;13:97. doi: 10.1186/1471-2407-13-97.
Results Reference
background
PubMed Identifier
27117712
Citation
Jones T, Lockhart JS, Mendelsohn-Victor KE, Duquette D, Northouse LL, Duffy SA, Donley R, Merajver SD, Milliron KJ, Roberts JS, Katapodi MC. Use of Cancer Genetics Services in African-American Young Breast Cancer Survivors. Am J Prev Med. 2016 Oct;51(4):427-36. doi: 10.1016/j.amepre.2016.03.016. Epub 2016 Apr 23.
Results Reference
result
PubMed Identifier
28197806
Citation
Katapodi MC, Duquette D, Yang JJ, Mendelsohn-Victor K, Anderson B, Nikolaidis C, Mancewicz E, Northouse LL, Duffy S, Ronis D, Milliron KJ, Probst-Herbst N, Merajver SD, Janz NK, Copeland G, Roberts S. Recruiting families at risk for hereditary breast and ovarian cancer from a statewide cancer registry: a methodological study. Cancer Causes Control. 2017 Mar;28(3):191-201. doi: 10.1007/s10552-017-0858-2. Epub 2017 Feb 14.
Results Reference
result
PubMed Identifier
29353367
Citation
Jones T, Duquette D, Underhill M, Ming C, Mendelsohn-Victor KE, Anderson B, Milliron KJ, Copeland G, Janz NK, Northouse LL, Duffy SM, Merajver SD, Katapodi MC. Surveillance for cancer recurrence in long-term young breast cancer survivors randomly selected from a statewide cancer registry. Breast Cancer Res Treat. 2018 May;169(1):141-152. doi: 10.1007/s10549-018-4674-5. Epub 2018 Jan 20.
Results Reference
result
PubMed Identifier
30187678
Citation
Katapodi MC, Ellis KR, Schmidt F, Nikolaidis C, Northouse LL. Predictors and interdependence of family support in a random sample of long-term young breast cancer survivors and their biological relatives. Cancer Med. 2018 Oct;7(10):4980-4992. doi: 10.1002/cam4.1766. Epub 2018 Sep 5.
Results Reference
result
PubMed Identifier
30385886
Citation
Nikolaidis C, Duquette D, Mendelsohn-Victor KE, Anderson B, Copeland G, Milliron KJ, Merajver SD, Janz NK, Northouse LL, Duffy SA, Katapodi MC. Disparities in genetic services utilization in a random sample of young breast cancer survivors. Genet Med. 2019 Jun;21(6):1363-1370. doi: 10.1038/s41436-018-0349-1. Epub 2018 Nov 2.
Results Reference
result

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

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