Riches, Katherine
(2020)
Determining the size of the problem: a validation study to improve the assessment of mid-line breast cancer related lymphoedema.
PhD thesis, University of Nottingham.
Abstract
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<0.05). No differences were seen in the tonometer measurements. Receiver Operator Characteristic (ROC) curves demonstrated that ultrasound and TDC measurements were able to distinguish between oedematous and non-oedematous breasts.
Threshold levels were produced which demonstrated good levels of sensitivity and specificity.
The number of clinician identified and patient reported signs and symptoms were higher in women with breast BCRL, although women without lymphoedema did report the presence of some of the symptoms. The breast lymphoedema symptom questionnaire (BLSQ) appears to be a valid tool and has potential to be used as a screening tool for breast BCRL.
QoL using the EORTC-QLQ-BR23 and the LYMQOL-Breast was lower in those with breast BCRL. Analysis undertaken confirmed the newly developed LYMQOL breast to be a valid tool.
Implications: The findings in this thesis have the potential to improve the assessment and recognition of breast BCRL. Ultrasound and TDC measurements can be used to enhance the diagnosis of breast BCRL.
In addition, the BLSQ and TDC could be used in breast cancer clinics as screening tools to identify patients who might have breast BCRL and warrant referral and assessment by a lymphoedema specialist.
Use of the signs and symptoms, applied by the clinical expert in this study, by lymphoedema therapists in routine clinical practice would improve the consistency of patient assessment.
LYMQOL-Breast can be added to the arm and leg versions available and used in clinical practice to assess QoL associated with breast lymphoedema.
Future research is required to test further the threshold levels proposed, test the reliability and responsiveness to change of these and the LYMQOL-Breast. A prospective longitudinal study using these tools and assessment techniques would provide more accurate information on the incidence of breast BCRL, the time course for development and potential resolution.
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