NCT00393406

Brief Summary

Lifestyle behaviors among women with a family history of breast cancer are likely to be influenced by a number of factors, including both objective risk factors and subjective risk, or perceived risk. The aims of this mixed method study are twofold and will be explored through both quantitative (i.e. secondary survey data) and qualitative data (i.e. personal in-depth interviews) derived from the Sister Study, a large epidemiologic study being conducted through the National Institute of Environmental Health Sciences, which is addressing risk factors for breast cancer in sisters of women who have had breast cancer. The quantitative aims include an exploration of lifestyle behaviors and behavioral differences between White and African American women, as well as well as an exploration of the relationships between lifestyle behaviors (i.e. varying levels of objective risk based on Gail model risk scores, medical risk-reducing factors (i.e. use of Tamoxifen or Raloxifene and/or prophylactic surgery), as well as additional factors that may be contributors to perceived risk. This aim will be addressed using data that have already been collected as part of the baseline activities for the Sister Study. The primary qualitative aim is to gain a better understanding about perceived risk and the relationship between perceived risk and lifestyle behaviors in both White and African American women with a family history of breast cancer. This aim requires the collection of new data through in-person interviews with between 28 and 40 women, depending on how many interviews are required to achieve "data saturation." The mixed method approach will be based on a "complementarity" model, which emphasizes the use of two different methods to address different aspects of the research problem. Results from both methods will become integrated into the discussion of the findings and it is expected that this approach will enrich the study and allow for elaboration of the quantitative results. The secondary data analysis will be derived from approximately 10,000 women, initially enrolled in the Sister Study, who are between the ages of 35 and 74 and have had at least one sister affected by breast cancer. Women for the qualitative interviews will be recruited from a cohort of Sister Study participants residing within North Carolina and will include equal numbers of both White and African American women. It is expected that 28 women will be needed for qualitative data saturati...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2008

Completed
Last Updated

July 2, 2017

Status Verified

October 28, 2008

First QC Date

October 26, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Objective RiskGail ModelSubjective RiskMedical Risk-Reducing StrategiesPhysical Activity, Diet, Alcohol UseBreast Cancer Risk

Eligibility Criteria

Age35 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Data from the first 20,000 women enrolled in the Sister Study will be utilized for the quantitative analysis.
  • Participants for the qualitative study will include women living in North Carolina who reside within a three and a half hour driving distance from the researcher.

You may not qualify if:

  • women will be excluded if they were adopted because a complete family history is unlikely to be known;
  • women will be excluded if they have had prior history of cancer, with the exception of non-melanoma skin cancer;
  • women from racial/ethnic groups classified as "other" will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (3)

  • Aiken LS, Fenaughty AM, West SG, Johnson JJ, Luckett TL. Perceived determinants of risk for breast cancer and the relations among objective risk, perceived risk, and screening behavior over time. Womens Health. 1995 Spring;1(1):27-50.

    PMID: 9373372BACKGROUND
  • Ainsworth BE, Haskell WL, Leon AS, Jacobs DR Jr, Montoye HJ, Sallis JF, Paffenbarger RS Jr. Compendium of physical activities: classification of energy costs of human physical activities. Med Sci Sports Exerc. 1993 Jan;25(1):71-80. doi: 10.1249/00005768-199301000-00011.

    PMID: 8292105BACKGROUND
  • Audrain J, Lerman C, Rimer B, Cella D, Steffens R, Gomez-Caminero A. Awareness of heightened breast cancer risk among first-degree relatives of recently diagnosed breast cancer patients. The High Risk Breast Cancer Consortium. Cancer Epidemiol Biomarkers Prev. 1995 Jul-Aug;4(5):561-5.

    PMID: 7549815BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityAlcohol Drinking

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorDrinking Behavior

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

October 24, 2006

Study Completion

October 28, 2008

Last Updated

July 2, 2017

Record last verified: 2008-10-28

Locations