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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612338
• Other study ID #: 5U48DP001901-03
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1290
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer in Women With a Strong Family History
• Breast Cancer in Young Women
• Breast Neoplasms

Intervention

Behavioral:
• Targeted
Targeted letter and booklet
• Enhanced Tailored
Tailored letter and booklet, enhanced family communication and support brochure

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan
United States	Michigan Department of Community Health	Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Michigan Department of Community Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 — View 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):4 — View 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 — View 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 — View 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. — View 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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast cancer screening	self report of mammogram and clinical breast exam	9 months
Primary	genetic counseling	self report of obtaining genetic counseling	9 months
Secondary	barriers to screening	Barriers and Facilitators to Mammography	9 months
Secondary	knowledge of breast cancer genetics	Genetic literacy	9 months