Determining the size of the problem: a validation study to improve the assessment of mid-line breast cancer related lymphoedema

Background: Lymphoedema can develop after treatment for breast cancer due to damage caused to the lymphatic drainage affecting the arm, breast and or chest wall. Most of the research on this topic has focused on the incidence and outcomes of breast cancer related lymphoedema (BCRL) of the arm. Despite the significant amount of research in this area, there is still much debate over the diagnostic criteria and the assessment techniques used. Lymphoedema can also affect the breast or chest wall but this area of BCRL does not appear to be as well studied. Although mid-line BCRL is recognised in the clinical setting the initial assessment and the techniques used to monitor the effectiveness of treatment currently rely on subjective assessment and patient report. Aims: The overall aim of this thesis was to improve the assessment and recognition of mid-line BCRL. The first objective included completion of two systematic literature searches and comprehensive reviews. These were undertaken to examine the available literature on the incidence, assessment and development of mid-line BCRL plus evaluation of the quality of life (QoL) tools currently available. This led to the development of the clinical study. The second objective involved the design and completion of the clinical study. This was developed to validate the objective assessment techniques identified from the literature, a patient completed symptom report tool and a QoL tool. Methods: A systematic search was performed. A review of the literature was completed to identify the incidence of mid-line BCRL, specifically when and how commonly it occurs and to evaluate the assessment techniques that have been utilised. The second review was undertaken to ascertain whether the QoL tools currently available were designed and validated for patients with mid-line BCRL. A clinical study was undertaken which recruited 89 women who had undergone breast cancer treatment and included those with and without breast BCRL. Blinded clinical assessment was used as the gold standard technique and overall determinant of the presence or absence of breast lymphoedema. Measurement of skin thickness by ultrasound scanning, local tissue water by tissue dielectric constant (TDC) and tissue indentation by tonometry was recorded. Breast cancer treatment and demographic details were documented. Participants each completed two QoL questionnaires and a breast lymphoedema symptom report tool. Results: The two reviews identified 116 unique papers, of which 27 focused on the incidence and assessment mid-line BCRL and 89 on QoL. The majority of the studies focussed on breast BCRL. There is a paucity of literature that included chest wall BCRL. The incidence of breast BCRL was presented in 9 studies and ranged from 9.6% to 75.5%. The range in the incidence reported is reflective of the variety in the study methodologies applied; including the sample size, the objective and subjective assessment tools utilised and the frequency and duration of the study assessments. A range of objective assessment techniques were identified. These included techniques that are commonly used to assess and monitor lymphoedema of the arm. It was apparent from the review why there currently isn’t a gold standard tool for assessment of mid-line BCRL and that further research needs to be undertaken. The QoL search identified 89 papers, which had utilised 24 different QoL tools. Most of the studies undertaken focused on arm BCRL and the impact of this on QoL. The literature demonstrated that BCRL is associated with reduced QoL. The QoL tools used in the studies varied and included generic and disease / condition specific QoL tools. Only two studies directly examined QoL in patients with mid-line BCRL. The review identified that the EORTC-QLQ-BR23 tool does include questions pertaining to breast symptoms, however, this has not been tested in patients with breast BCRL. In the clinical study, breast lymphoedema was confirmed in 40 women (44.9%) with the lower half of the breast most commonly affected. Of this group, it had been previously undiagnosed in 29/40 (72.5%). Increased BMI, larger Bra size, increased number of positive lymph nodes, axillary surgery, receipt of chemotherapy and increased NPI were all associated with the presence of breast lymphoedema (p<0.05). Ultrasound and TDC measurements were significantly higher in the lymphoedema group (p