Short summary

Lymphedema occurs in 30 to 50% of women undergoing axillary lymph node dissection. Individuals with lymphedema experience persistent pain, decreased function, body image disturbance, and anxiety, resulting in a considerable decline in physical, psychological, and social well-being. To better understand the impact of lymphedema on health-related quality of life (HRQOL), rigorously developed, valid, and reliable patient-reported outcome measures (PROMs) are needed to quantify outcomes of lymphedema and its treatment from the patient's perspective. The specific aim of this study is to develop new BREAST-Q scales that measure these outcomes of lymphedema.

Rationale

Lymphedema occurs in 30 to 50% of women undergoing axillary lymph node dissection and refers to the fibro-adipose deposition and swelling of tissue as a result of having a chronic accumulation of interstitial fluid [1]. Individuals with lymphedema experience persistent pain, decreased function, body image disturbance, and anxiety, resulting in a considerable decline in physical, psychological, and social well-being [2-3]. Recent studies have shown that some patients may develop symptoms of lymphedema without having any objective changes to their arm, indicating that clinical measurements may underestimate the incidence and impact of lymphedema [4]. 

To better understand the impact of lymphedema on health-related quality of life (HRQOL), rigorously developed, valid, and reliable patient-reported outcome measures (PROMs) are needed to quantify outcomes of lymphedema and its treatment from the patient's perspective [5-6]. As evidence-based medicine is rapidly setting a standard for clinical decision-making in the care of breast cancer patients, the availability of PROM is essential.

The BREAST-Q includes three breast cancer modules (i.e., mastectomy, breast-conserving therapy, and reconstructive surgery) and measures satisfaction with breasts, outcome of treatment, experience of care, and HRQOL in terms of psychosocial, sexual, and physical wellbeing. Currently, the BREAST-Q does not include scales specific to lymphedema. To measure lymphedema, and the impact that it has on how a patient feels and functions will require the development of new, specific scales. 

The specific aim of the proposed study is to develop new BREAST-Q scales that measure outcomes of lymphedema from the patient perspective. It is anticipated that these scales will facilitate research and the advancement of new treatment techniques, as well as improved patient care and outcomes.

Description of the cohort

Women, aged 18 years or older, with a history of breast cancer who had undergone breast surgery (i.e., breast-conserving therapy or a mastectomy), and have the ability to complete a questionnaire online, in Danish will be included. 

Data and biological material

Questionnaires

Women who are interested and meet the inclusion criteria will be asked to complete the new BREAST-Q lymphedema scales. All participants will be asked to provide demographic (e.g., height, weight, age, bra cup size,) and clinical (date of diagnosis, type, and timing of breast reconstruction) information.

Collaborating researchers and departments

Department of plastic surgery OUH

• MD, Lotte Poulsen

Department of plastic surgery OUH

• stud.med., Amalie Lind Jacobsen

Department of pediatrics Mcmaster University, Hamilton, Canada

• Professor of Pediatrics, Anne Klassen