Sharon L. Kilbreath

Background: Lymphoedema of the breast is a potential consequence of breast cancer treatment. Questionnaires exist to quantify breast symptoms but evidence for measurement properties is limited. This study aimed to evaluate measurement properties of breast lymphoedema questionnaires and report on frequency and severity of breast symptoms in women with breast cancer. Methods: Women following breast conserving surgery and radiotherapy were recruited. Four questionnaires, Breast Lymphoedema Severity Symptom questionnaire (BLYSS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Symptom Subscale (EORTC-QLQ-BSS), Lymphoedema Symptom Intensity and Distress scale–Trunk (LSIDS-T) and Breast Oedema Bother scale (BOB), were completed three and nine-months after radiotherapy. Measurement properties and breast symptoms were evaluated. Results: Questionnaires were completed by 164 women at three-months, and 152 at nine-months post radiotherapy. Internal consistency was strong for all questionnaires (McDonald’s Omega and Cronbach’s ⍺ ≥0.7). Correlation between BLYSS and EORTC-QLQ-BSS and BOB visual analogue scale (BOB-VAS) met the hypothesised level (r _s ≥ 0.7) demonstrating construct validity. Exploratory factor analysis demonstrated single factors for individual tools and four factors when all four questionnaires were combined: pain, swelling, breast sensations and hardness. Responsiveness was high for BLYSS and moderate for EORTC-QLQ-BSS and BOB-VAS. Over half the women experienced symptoms ≥twice/week at mild-extreme severity. Breast pain, hardness, oversensitivity and swelling were most reported symptoms. Conclusion: The BLYSS demonstrated the strongest measurement properties among the PROMs evaluated with strong internal consistency, construct validity and responsiveness. Breast symptoms were commonly experienced by women after breast cancer treatment.

Background/Objectives: Physical activity benefits women with metastatic breast cancer. Past trials are typically well-resourced and supervised, but home-based interventions may be preferable and more accessible. This pilot trial evaluated the feasibility and preliminary efficacy of a remotely delivered behaviour change intervention aiming to increase physical activity for women with metastatic breast cancer. Methods: A 12-week, two-arm trial involved 20 women with metastatic breast cancer randomised 1:1 to a generic recommendation group or behaviour change group. Both groups received a physical activity recommendation, Fitbit^® watch, diary, and nine phone/video call sessions. The behaviour change group received individualised advice around physical activity benefits, motivation, barriers, and social support; the generic recommendation group completed a recurring symptom questionnaire. Feasibility outcomes were recruitment, retention and adherence rates. Acceptability was evaluated with a structured interview at trial completion. Preliminary efficacy outcomes included 5-day Actigraph wear, 6 min walk distance, 30 s sit-to-stands, and questionnaires for self-reported physical activity, quality-of-life, fatigue, behavioural factors, and patient-specific function. Results: Recruitment, retention, and adherence rates were 63% (n = 20/32), 80% (n = 16/20), and 76% (137/180 sessions), respectively. Participants across both groups reported that participation was acceptable, and their behaviour change was perceived as sustainable. Preliminary change scores for efficacy measures favoured the behaviour change group, except some quality-of-life and behavioural factor subscales. Conclusions: Participants were receptive to the trial, and feasibility and efficacy measures were positive. This indicates that a behaviour change intervention for unsupervised physical activity is acceptable and can be beneficial to women with metastatic breast cancer, warranting further exploration.

Background: A common side effect of breast cancer treatment is breast cancer–related lymphedema (BCRL), which is associated with many symptoms, such as swelling, heaviness, tightness, pain, discomfort and poor quality of life. The breast cancer and lymphedema symptom experience index (BCLE‐SEI) captures the presence of BCRL‐related symptoms and distress. However, the BCLE‐SEI is not available in Marathi, one of the most commonly spoken Indian languages. The purpose of this study was to translate and validate the BCLE‐SEI in Marathi. Methodology: The BCLE‐SEI was forward‐ and backward‐translated, and the consolidated back translation was checked for equivalence following established guidelines. The BCLE‐SEI‐Marathi was then validated among 169 Marathi‐speaking women with or at risk of developing BCRL. Content validity, structural validity, internal consistency, test–retest reliability, construct validity (through hypothesis testing) and known group validity were tested. Three different thresholds were used when testing known group validity. Results: Content validity of the BCLE‐SEI‐Marathi was confirmed by 98% of the participants. Exploratory factor analysis identified two factors in the symptom occurrence subscale and three factors in the symptom distress subscale, which explained 49% and 53.8% of the total sample variance, respectively. Internal consistency of dimensions (factors) ranged from α = 0.82 to 0.94. Construct validity was established through hypothesis testing. The test–retest reliability was strong (Spearman’s rho of 0.88 ( p < 0.01, 95% CI: 0.8–0.9)). The BCLE‐SEI total score was able to distinguish the participants with BCRL from those at risk for BCRL. Conclusion: This study demonstrated that the BCLE‐SEI‐Marathi questionnaire is a valid and reliable tool to assess the occurrence and distress of symptoms in Marathi‐speaking women with or at risk of BCRL. Trail Registration: Clinical Trials Registry India: CTRI/2017/11/010326

Lipedema diagnosis is heavily reliant on patient history. Various objective assessments have been suggested; however, a standardized measurement process is lacking. A systematic review was undertaken to identify which imaging and measurement tools are used in lipedema quantification and to review their protocols. Six databases were searched with two reviewers screening citations for inclusion. Full peer-reviewed publications that included defined lipedema diagnosis criteria, no male cases within comparative cohorts, and used an imaging or measurement tool to quantify lipedema were included. Twenty studies met the inclusion criteria using 13 different tools to quantify individual physical lipedema characteristics to either enable differential diagnosis, and/or quantify treatment effect: tape measure, perometry, durometry, tonometry, bioimpedance spectroscopy, tissue di-electric constant, ultrasound, Dual-Energy X-ray Absorptiometry, magnetic resonance imaging (MRI), noncontrast MRI lymphangiography, Indocyanine green lymphography, lymphoscintigraphy, and dynamic lymphangiography. Eight imaging and five measurement tools assessed lymphatic transport disturbances ( n = 8), limb size/volume ( n = 4), adipose tissue thickness/mass/volume ( n = 3), and tissue fluid presence ( n = 2). Multiple tools were only used in studies completed in 2020 or later. A lack of consistency exists in tool protocols, measurement locations, and outcome analysis. Limited reporting of clinimetrics with data derived from small cohorts and heterogenous populations impacted the ability to recommend tools for clinical practice and research. Various tools were used for objective lipedema assessment; however, consistency in approach was lacking. Further investigations are required to establish the validity and reliability of measurement and imaging tools, protocols, measurement points, and outcome reporting/interpretation to quantify the physical attributes of lipedema.

Background: Breast lymphedema after breast cancer is challenging to quantify. Three-dimensional (3D) surface imaging is one available technique to measure breast volume, however, the measurement properties of available software programs have not been fully determined. The aim of this study was to determine equivalency of measurements with two software programs as well as reliability, standard error of measurement (SEM), and smallest detectable change (SDC). Methods and Results: Retrospective three-dimensional surface imaging (3D-SI) of 100 breasts taken before or after breast conserving surgery for breast cancer were retrieved for reliability analysis. Three assessors followed a standardized measurement technique using two software programs, Vectra ^® 3D Analysis Module (VAM) and Breast Sculptor ^® . Mean breast volume was 489.9 ± 206 cc using VAM and 480.1 ± 229.1 cc using Breast Sculptor. Lin's concordance showed poor agreement between programs (0.81–0.88). Measurements using VAM had excellent intra- and inter-rater reliability with SEM = 4.1% for one assessor and 8.7% for multiple assessors. Breast Sculptor also had excellent intra-rater and substantial inter-rater reliability but the SEM was much larger at 14.5% (intra-rater) and 19.1% (inter-rater). The SDC value was lowest for VAM and a single rater with 56 cc indicating a meaningful change beyond measurement error. Conclusion: Breast volume measurements captured with 3D-SI using VECTRA-XT are highly reliable, but the volumes, SEM, and SDC varied between the two software programs. Measurement error was lowest with VAM software. Although the usefulness of VECTRA-XT and VAM software to detect change in breast volume is promising, further solutions to reduce measurement error are required to improve clinical utility to measure breast lymphedema.

Background: The safety and feasibility of using kinesiotape as a short-term alternative treatment to compression garments or gloves for hand lymphedema have not been examined. The aim of this study was to examine if kinesiotape could maintain size and extracellular fluid (ECF) volume of the hand and forearm, as well as upper limb function and quality of life for women with secondary hand lymphedema. Methods and Results: Six women with secondary hand lymphedema underwent pretreatment measurements, including hand and digit size using a tape measure; ECF volume using bioimpedance spectroscopy; and patient-reported outcome measurements of upper limb function and quality of life. Kinesiotape was then applied to the dorsum of the hand and left for 48 h, during which participants were asked not to wear compression garments. Posttreatment measurements were completed after kinesiotape removal. Changes in measurements were compared to the smallest detectable change (SDC). Hand size did not change more than the SDC; however, a single affected digit increased in circumference by more than the SDC. Changes of the whole arm ECF volume were less than the SDC. The ECF volume of the dorsum of the hand increased in one and decreased in another participant. The forearm ECF volume decreased in two participants. Upper limb function and quality of life did not change. No adverse event was reported. Conclusion: Short-term kinesiotape use appears to be safe in maintaining the physical presentation of hand lymphedema. However, these results should be examined in a larger sample. The feasibility of using kinesiotape as an alternative treatment to compression requires further investigation. Clinical Trial Registration number: ACTRN12618001232224p, July 23, 2018 retrospectively registered.

Purpose: Breast lymphoedema is a possible side effect of breast conserving surgery, but it is poorly understood. This is due, in part, to difficulty assessing the breast. This systematic review described outcome measures that quantify breast lymphoedema signs and symptoms and evaluated the measurement properties for these outcome measures. Method: Seven databases were searched using terms in four categories: breast cancer, lymphoedema and oedema, clinician reported (ClinROM) and patient reported outcome measures (PROM) and psychometric and measurement properties. Two reviewers independently reviewed studies and completed quality assessments. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology was used for studies including measurement property evidence. Results: Fifty-six papers were included with thirteen questionnaires, eight patient-reported rating scales, seven physical measures, seven clinician-rating scales and four imaging techniques used to quantify breast lymphoedema. Based on COSMIN methodology, one ClinROM had sufficient reliability, ultrasound measuring dermal thickness. Tissue dielectric constant (TDC) measuring local tissue water had promising reliability. Four questionnaires had sufficient content validity (BLYSS, BLSQ, BrEQ and LYMQOL-Breast). Conclusions: Ultrasound is recommended to reliably assess breast lymphoedema signs. No PROM can be recommended with confidence, but BLYSS, BLSQ, BrEQ and LYMQOL-Breast are promising. Further research is recommended to improve evidence of measurement properties for outcome measures. Implications for Cancer Survivors: There are many approaches to assess breast lymphoedema, but currently, only ultrasound can be recommended for use, with others, such as TDC and questionnaires, showing promise. Further research is required for all approaches to improve evidence of measurement properties.

PURPOSE: To determine whether prophylactic use of compression sleeves prevents arm swelling in women who had undergone axillary lymph node dissection for breast cancer surgery. METHODS: Women (n = 307) were randomly assigned to either a compression or control group. In addition to usual postoperative care, the compression group received two compression sleeves to wear postoperatively until 3 months after completing adjuvant treatments. Arm swelling was determined using bioimpedance spectroscopy (BIS) thresholds and relative arm volume increase (RAVI). Incidence and time free from arm swelling were compared using Kaplan-Meier analyses. Hazard ratios (HRs) were estimated from Cox regression models for BIS and RAVI thresholds independently. In addition, time to documentation of the first minimally important difference (MID) in four scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer–specific (BR23) questionnaire was analyzed. RESULTS: The HR for developing arm swelling in the compression group relative to the control group was 0.61 (95% CI, 0.43 to 0.85; P = .004) on the basis of BIS and 0.56 (95% CI, 0.33 to 0.96; P = .034) on the basis of RAVI. The estimated cumulative incidence of arm swelling at 1 year was lower in the compression group than the control group on the basis of BIS (42% v 52%) and RAVI (14% v 25%). HRs for time from baseline to the first change of the minimally important difference were not statistically significant for any of the four scales of EORTC QLQ-30 and BR23 questionnaires. CONCLUSION: Prophylactic use of compression sleeves compared with the control group reduced and delayed the occurrence of arm swelling in women at high risk for lymphedema in the first year after surgery for breast cancer.