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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519974
• Other study ID #: 07-087
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: N/A
• First received: August 21, 2007
• Last updated: September 29, 2015
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• counseling intervention

• study of socioeconomic and demographic variables

Procedure:
• management of therapy complications

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New School for Social Research	New York	New York
United States	Ralph Lauren Center for Cancer Care and Prevention	New York	New York
United States	SHARE, Incorporated	New York	New York
United States	Spirit of Hope	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy		2 years	No
Primary	Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy		2 years	No