Skip to main content
OpenTrials
Completed

NCT Number: NCT00519974

Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women

RATIONALE: Learning about the reasons for choosing to have, or not to have, breast reconstruction after mastectomy for breast cancer may help doctors understand why black or Latina women may or may not undergo breast reconstruction.

PURPOSE: This clinical trial is studying factors affecting decisions about breast reconstruction after mastectomy in black and Latina women.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

OBJECTIVES:

  • Interview black and Latina women about their reasons for choosing to have, or not to have, breast reconstruction after mastectomy for breast cancer.
  • Describe the context in which black and Latina women make decisions about breast reconstruction.
  • Explore similarities and differences in factors affecting decision-making among black and Latina women.
  • Identify factors that contribute to the low utilization of breast reconstruction among ethnic minority women.

OUTLINE: This is a multicenter study.

Patients undergo a 1-hour interview to evaluate their rationale for choosing to have, or not to have, breast reconstruction after mastectomy. Interviews are conducted by a woman of the same ethnic background as the patient. Key factors influencing a patient's decision to consider having breast reconstruction are explored during the interview, including availability of educational materials on breast reconstruction and the adequacy of this information. Patients are asked to examine personal factors influencing their decision, such as feelings about living with or without a reconstructed breast; concerns about reconstructive surgery and its risks; potential complications; and impact of reconstructive surgery on sexuality and body image. Social and cultural factors are also evaluated, including influence of family and friends; degree of support for the patient's decision to have surgery; racial or ethnic differences in patient's preferences; and cultural values. Access-related factors, such as financial cost, insurance availability, or physician referral practices, are also explored.

At the end of the interview, patients may be referred to Memorial Sloan-Kettering Cancer Center or Ralph Lauren Center for Cancer Care and Prevention for oncologic surveillance or for additional information on breast reconstruction. Patients may also be contacted after the interview to answer follow-up questions, to clarify topics previously discussed, or to provide further input or feedback on preliminary study findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Have undergone mastectomy* (with or without reconstruction) for breast cancer within the past 3 years AND meets 1 of the following criteria:
  • Self-identified as being black
  • Self-identified as being Latina NOTE: *Patients scheduled to undergo mastectomy are eligible
  • Recruited from one of the following cancer centers or breast cancer support organizations:
  • Memorial Sloan-Kettering Cancer Center or Ralph Lauren Center for Cancer Care and Prevention
  • Patients are identified by their physician (e.g., oncologist, breast surgeon), the protocol investigator, a member of the research team, and/or medical chart review
  • Spirit of Hope or LatinaSHARE
  • Patients are identified by the director of the support organization or the support group leader
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No cognitive impairment that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

counseling intervention

Other

study of socioeconomic and demographic variables

Other

management of therapy complications

Procedure

psychosocial assessment and care

Procedure

Primary outcomes

  1. Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy

    Time frame: 2 years

  2. Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2007
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.