NCT01488357

Brief Summary

Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life and body image.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

October 12, 2011

Last Update Submit

April 25, 2017

Conditions

Breast Cancer

Keywords

Breast cancerUNCLinebergerBreast ReconstructionMastectomy

Outcome Measures

Primary Outcomes (1)

  • Treatment Concordance

    The investigator will assess patient preferences pre-operatively using conjoint analysis. The investigator will determine if these preferences are concordant with the patient's treatment decision.

    Time of Surgery decision which is an average of 2-4 weeks before surgery.

Secondary Outcomes (4)

  • Body Image

    18 months post operatively

  • Satisfaction with Decisions

    18 months post-operatively

  • Quality of Life

    18 months post-operatively

  • Knowledge

    Pre-operatively at time of decision making which is an average of 2-4 weeks before surgery.

Study Arms (1)

Early stage breast cancer patients receiving mastectomy

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women undergoing mastectomy at UNC for treatment of Stage I, II, or III breast cancer or DCIS, or for prophylaxis

You may qualify if:

  • Women 21 years of age or older
  • Having a mastectomy at UNC for treatment of Stage I, II, or III breast cancer, ductal carcinoma in situ (DCIS) or for prophylaxis

You may not qualify if:

  • Stage IV breast cancer
  • Women who do not speak English
  • Severe psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clara N Lee, MD, MPP

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2011

First Posted

December 8, 2011

Study Start

June 1, 2012

Primary Completion

February 27, 2014

Study Completion

June 30, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

US(1)