Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives
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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 |
- 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
- 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: | March 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 |
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| Contact: Maria C. Katapodi, PhD | 734-647-0178 | mkatapo@umich.edu |
| United States, Michigan | |
| University of Michigan School of Nursing | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Maria C. Katapodi, PhD 734-647-0178 mkatapo@umich.edu | |
| Principal Investigator: Maria C. Katapodi, PhD | |
| 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: | June 1, 2012 |
| 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 May 21, 2013