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OpenTrials
Completed

NCT Number: NCT01488357

Patient Preferences for Breast Reconstruction After Mastectomy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Treatment Concordance

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

    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.

Secondary outcomes

  1. Body Image

    Time frame: 18 months post operatively

    Body Image Scale

  2. Satisfaction with Decisions

    Time frame: 18 months post-operatively

    Satisfaction with Decisions Scale

  3. Quality of Life

    Time frame: 18 months post-operatively

    Breast-Q and Forecasting measures

  4. Knowledge

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

    The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • North Carolina TraCS Institute

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Dec 8, 2011
Registry last updated
Apr 26, 2017

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.

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