NCT00519974

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

August 21, 2007

Last Update Submit

September 29, 2015

Conditions

Breast CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (2)

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

    2 years

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

    2 years

Interventions

counseling interventionOTHER
study of socioeconomic and demographic variablesOTHER
management of therapy complicationsPROCEDURE
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Black and Latina female breast cancer patients who have undergone or scheduled to undergo mastectomy within the past 3 years will be identified by their physicians (e.g., medical oncologists, breast surgeon, plastic surgeon) at MSKCC and RLCCCP or by the advocacy center to which they belong.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

New School for Social Research

New York, New York, 10003, United States

Location

Spirit of Hope

New York, New York, 10030, United States

Location

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, 10035, United States

Location

SHARE, Incorporated

New York, New York, 10036, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Andrea L. Pusic, MD, MHS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Karen Hurley, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

US(6)