Patient Preferences for Breast Reconstruction After Mastectomy
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Patient Preferences for Breast Reconstruction After Mastectomy |
- Treatment Concordance [ Time Frame: Time of Surgery decision which is an average of 2-4 weeks before surgery. ] [ Designated as safety issue: No ]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.
- Body Image [ Time Frame: 18 months post operatively ] [ Designated as safety issue: No ]Body Image Scale
- Satisfaction with Decisions [ Time Frame: 18 months post-operatively ] [ Designated as safety issue: No ]Satisfaction with Decisions Scale
- Quality of Life [ Time Frame: 18 months post-operatively ] [ Designated as safety issue: No ]Breast-Q and Forecasting measures
- Knowledge [ Time Frame: Pre-operatively at time of decision making which is an average of 2-4 weeks before surgery. ] [ Designated as safety issue: No ]The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.
| Estimated Enrollment: | 133 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Early stage breast cancer patients receiving mastectomy |
Detailed Description:
Breast reconstruction after mastectomy is an important treatment option for the many thousands of women who undergo mastectomy each year. Its insurance coverage is mandated by federal law. Many women who want reconstruction, particularly women from racial and ethnic minorities, never receive it, and some women who undergo reconstruction regret having it, raising concern about the quality of decisions about the procedure. Little is known about the quality of breast reconstruction decisions, defined as the extent to which decisions are informed and concordant with patients' preferences. A lack of reliable methods for evaluating preference concordance has resulted in a paucity of research in this area. Deciding about breast reconstruction requires a patient to predict how she would feel after the procedure, a process called affective forecasting. Extensive psychological research has shown that people have difficulty making accurate predictions about how they will feel, tending to overestimate the effects of disease and treatments on their well-being and to underestimate their ability to adapt to change and the effects of other aspects of their lives. Despite the importance of affective forecasting to decisions about breast reconstruction, no research has examined this aspect of those decisions. The investigator proposes to conduct a pilot cohort study of breast cancer patients undergoing mastectomy, with or without reconstruction with the following specific aims: Aim 1: to evaluate whether patients make informed decisions about breast reconstruction that are concordant with their preferences; Aim 2: to assess the accuracy of patients' preoperative predictions about their post-operative body image and well-being; and Aim 3: to assess the effects of breast reconstruction on quality of life and body image and the potential modification of those effects by preference concordance.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult women undergoing mastectomy at UNC for treatment of Stage I, II, or III breast cancer or DCIS, or for prophylaxis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Stage IV breast cancer
- Women who do not speak English
- Severe psychiatric illness
Contacts and Locations| Contact: Lillian Burdick | 919-843-4304 | lillian_burdick@med.unc.edu |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Clara N Lee, MD, MPP | |
| Principal Investigator: | Clara N Lee, MD, MPP | University of North Carolina |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01488357 History of Changes |
| Other Study ID Numbers: | 11-0119, 1K07CA154850-01A1 |
| Study First Received: | October 12, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Breast cancer UNC Lineberger Breast Reconstruction Mastectomy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013