Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

patients will fill out two questionnaires post surgery

questionnaires

Patient will fill out questionnaire before and 3 to 6 months after treatment.

Andrea Pusic, M.D., M.H.S.

The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.

Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery

Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument

McMaster University

University College, London

Dartmouth-Hitchcock Medical Center

University of British Columbia

Johns Hopkins University

University of Pittsburgh

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Rare Diseases

Hypertrophy

Pathological Conditions, Anatomical

Gigantomastia

Women who have had/have breast cancer and will have/have had a breast reconstruction.

Women who have had/will have a breast reduction due to breast hypertrophy.

Breast reconstruction after breast cancer.

Breast reconstruction

Breast reduction due to breast hypertrophy.

Breast reduction

Emma Hansson, MD, PhD

Emma Hansson, PhD

The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.

Women who are biological women and identify as cis-women.

Validation of Scales in Reconstructive Breast Surgery

Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.

EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.

The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.

The Clavien-Dindo system is based on ranking the severity of the intervention required to treat a given complication, as follows: grade I includes deviations from the postoperative course without the need for pharmacological treatment or surgical/endoscopic/radiological intervention; grade II complications require pharmacological treatment, blood transfusion, or total parental nutrition; grade III complications require surgical/endoscopic/radiological intervention; grade IV includes life-threatening complications, including those involving the central nervous system, that require intensive care treatment; and grade V includes complications that result in death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery	NCT00605670	Breast Cancer Breast Surgery Breast Reconstr... Breast Reductio... Breast Augmenta...	questionnaires questionnaires	18 Years - 85 Years	Memorial Sloan Kettering Cancer Center
Validation of Scales in Reconstructive Breast Surgery	NCT05233891	Breast Cancer Breast Hypertro...	Breast reconstr... Breast reductio...	18 Years - 100 Years	Vastra Gotaland Region
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery	NCT00605670	Breast Cancer Breast Surgery Breast Reconstr... Breast Reductio... Breast Augmenta...	questionnaires questionnaires	18 Years - 85 Years	Memorial Sloan Kettering Cancer Center
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery	NCT00605670	Breast Cancer Breast Surgery Breast Reconstr... Breast Reductio... Breast Augmenta...	questionnaires questionnaires	18 Years - 85 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for breast reduction