NCT01612338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,290

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 22, 2019

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

June 1, 2012

Last Update Submit

August 20, 2019

Conditions

Breast CancerBreast Cancer in Young WomenBreast Cancer in Women With a Strong Family History

Keywords

breast canceryoung age of onsetfamily historyscreening interventionsfamily support

Outcome Measures

Primary Outcomes (2)

  • breast cancer screening

    self report of mammogram and clinical breast exam

    9 months

  • genetic counseling

    self report of obtaining genetic counseling

    9 months

Secondary Outcomes (2)

  • barriers to screening

    9 months

  • knowledge of breast cancer genetics

    9 months

Study Arms (2)

Targeted

EXPERIMENTAL

Targeted letter and booklet

Behavioral: Targeted

Tailored

EXPERIMENTAL

Tailored letter and booklet, enhanced family communication and support brochure

Behavioral: Enhanced Tailored

Interventions

TargetedBEHAVIORAL

Targeted letter and booklet

Targeted
Enhanced TailoredBEHAVIORAL

Tailored letter and booklet, enhanced family communication and support brochure

Tailored

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For breast cancer survivors
  • Female
  • 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
  • years of age
  • US resident
  • Able to read and understand English
  • Unaffected with any type of cancer
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

Michigan Department of Community Health

Lansing, Michigan, 48913, United States

Location

Related Publications (7)

  • 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.

    PMID: 23448100BACKGROUND

  • 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.

    PMID: 27117712RESULT

  • 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.

    PMID: 28197806RESULT

  • 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.

    PMID: 29353367RESULT

  • 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.

    PMID: 30187678RESULT

  • 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.

    PMID: 30385886RESULT

  • Ellis KR, Koechlin H, Rudaz M, Gerido LH, Hecht HK, Jones C, Raji D, Northouse L, Katapodi M. Predictors and Interdependence of Quality of Life in a Random Sample of Long-Term Young Breast Cancer Survivors and Their Biological Relatives. Cancer Med. 2024 Oct;13(20):e70328. doi: 10.1002/cam4.70328.

    PMID: 39470180DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maria C. Katapodi, PhD

    University of Michigan School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 5, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

August 22, 2019

Record last verified: 2014-10

Locations

US(2)