Self-Managed Surveillance for Breast Cancer–Related Upper Body Issues: A Feasibility and Reliability Study

Bolette S Rafn, Chiara A Singh, Julie Midtgaard, Pat G Camp, Margaret L McNeely, Kristin L Campbell. Physical Therapy, Volume 100, Issue 3, March 2020, Pages 468–476.

BACKGROUND: Early identification of breast cancer-related upper body issues is important to enable timely physical therapist treatment.

OBJECTIVE: This study evaluated the feasibility and reliability of women performing self-managed prospective surveillance for upper body issues in the early postoperative phase as part of a hospital-based physical therapy program.

DESIGN: This was a prospective, single-site, single-group feasibility and reliability study.

METHODS: Presurgery arm circumference measurements were completed at home and at the hospital by participants and by a physical therapist. Instruction in self-measurement was provided using a video guide. After surgery, all circumference measurements were repeated along with self-assessment and therapist assessment for shoulder flexion and abduction active range of motion. Feasibility was determined by recruitment/retention rates and participant-reported ease of performing self-measurements (1 [very difficult] to 10 [very easy]). Reliability was determined as intrarater reliability, interrater reliability, and agreement.

RESULTS: Thirty-three women who were 53.4 (SD = 11.4) years old participated, with recruitment and retention rates of 79% and 94%, respectively. Participant-reported ease of measurement was 8.2 (SD = 2.2) before surgery and 8.0 (SD = 1.9) after surgery. The intrarater reliability and interrater reliability were excellent before surgery (intraclass correlation coefficient [ICC] ≥ 0.94; 95% confidence interval = 0.87-0.97) and after surgery (ICC ≥ 0.91; 95% confidence interval = 0.76-0.96). Agreement between self-assessed and therapist-assessed active shoulder flexion (κ = 0.79) and abduction (κ = 0.71) was good. LIMITATIONS: Further testing is needed using a prospective design with a longer follow-up to determine whether self-managed prospective surveillance and timely treatment can hinder the development of chronic breast cancer-related upper body issues.

CONCLUSIONS: Self-measured arm circumference and shoulder range of motion are reliable, and their inclusion in a hospital-based program of prospective surveillance for upper body issues seems feasible. This approach may improve early detection and treatment.

Integrating Augmented Reality Tools in Breast Cancer Related Lymphedema Prognostication and Diagnosis.

Invernizzi M1, Runza L2, De Sire A1, Lippi L1, Blundo C3, Gambini D4, Boldorini R5, Ferrero S6, Fusco N7. J Vis Exp. 2020 Feb 6;(156).

Breast cancer related lymphedema (BCRL) is a detrimental condition characterized by fluid accumulation in the upper limb in breast cancer patients subjected to axillary surgery and/or radiations. Its etiology is multifactorial and include also tumor-specific pathological features, such as lymphovascular invasion (LVI) and extranodal extension (ENE). To date, no widely employed guidelines for the early diagnosis of BCRL are available. Here, we illustrate a protocol for a digitally assisted BCRL assessment using a 3D laser scanner (3DLS) and a tablet computer. It has been specifically optimized in a discovery cohort of high-risk breast cancer patients. This study provides a proof-of-principle that augmented reality tools, such as 3DLS, can be incorporated into the clinical workup of BCRL to allow for a precise, reproducible, reliable, and cheap diagnosis.

Bioimpedance Spectroscopy of the Breast.

Ward LC1, Degnim AC2, Dylke ES3, Kilbreath SL3. Lymphat Res Biol. 2020 Feb 17

Background: Bioimpedance spectroscopy (BIS) measurements of breast lymphedema poses practical and technical challenges, in particular the determination of the resistance at zero frequency (R0), the index of change in breast lymph content. Conventionally, R0 is calculated from data analysis by using a procedure eponymously known as Cole modeling, a method that is error-prone in the breast. The aim of this study was to evaluate polynomial curve fitting as an alternative analytic procedure.

Methods and Results: A sub-set of breast BIS measurements from 41 women with self-ascribed breast lymphedema obtained as part of the Breast Edema Exercise Trial (BEET) were analyzed by both the Cole and polynomial methods. BIS files for all subjects were able to be analyzed by using the polynomial method but only 73% and 88% of data files were analyzed for the affected and unaffected breasts, respectively, by using the Cole method. For those files that were capable of being analyzed by both methods, R0 values were highly correlated (r = 0.99) but with a small (1.6%) although statistically significant difference (paired t test, p < 0.001) between methods. Conclusions: Analysis of BIS data using polynomial curve fitting is an acceptable and robust alternative to Cole modeling, particularly where impedance measurements are susceptible to technical sources of error of measurement. The small magnitude of difference observed between methods is unlikely to lead to misclassification of patients with lymphedema based on BIS assessment.

Feasibility of Bioimpedance Analysis to Assess the Outcome of Complex Decongestive Therapy in Cancer Treatment-Related Lymphedema.

Cho KH1, Han EY2, Lee SA3, Park H4, Lee C4, Im SH5. Front Oncol. 2020 Feb 11;10:111.

Background: Cancer treatment-related lymphedema (CTRL) affects patients physically, psychologically and emotionally, and remains a significant quality of life issue among patients with cancer. Reliable methods to measure changes in lymphedema are required for early detection, acute intensive treatment, and long-term management. Here, we evaluated the use of bioimpedance analysis (BIA) as a tool to measure lymphedema before and after treatment.

Patients and Methods: Patients with CTRL who were admitted to a secondary university hospital between October 2017 and July 2018 for complex decongestive therapy (CDT) were eligible for this prospective cohort study. Circumferential measure (CM) and BIA were used to evaluate lymphedema at admission (initial) and before discharge (follow-up, FU). Volume was calculated from the CM using the truncated cone formula. The inter-limb ratios (ILRs) of the circumference, volume, and impedance were also calculated as the unaffected limb to affected limb. Each parameter before and after treatment and correlations between parameters also were analyzed.

Results: A total of 29 patients (12 upper- and 17 lower-extremity CTRL) completed were included in this analysis. Absolute value and the ILRs of circumference, volume or impedance, and extracellular water/total body water (ECW/TBW) were significantly improved at FU (p < 0.01, p < 0.05). The initial and FU absolute values, ILRs, ECW/TBW correlated significantly with each other (p < 0.01, p < 0.05). The cutoff values of ECW/TBW for moderate and severe degree of CTRL were 0.3855 and 0.3955, respectively. The changes of ILRs between initial and FU assessments were significantly different among three groups according to lymphedema severity (p < 0.01, p < 0.05). Conclusions: BIA data correlates significantly with clinical measurement, and therefore can be a practical tool in monitoring outcome measure after lymphedema treatment. In addition, BIA is more sensitive to subtle changes in lymphedema, and therefore can be useful for the long-term maintenance of lymphedema.

Interrater Reliability of Dynamic Muscle Testing After Breast Cancer Surgery in Women at High Risk of Lymphedema: To Improve Quality in Clinical Practice.

Korsholm-Rosfort T1, Larsen S1, Aagaard T2,3,4, Ammitzbøll G5,6, Dalton SO5,6. Integr Cancer Ther. 2020 Jan-Dec;19.

Background: The purpose of this study is to determine the interrater reliability of dynamic muscle tests in the early rehabilitation phase in women after breast cancer surgery with axillary lymph node dissection (ALND) based on the “preventive intervention against lymphedema after breast cancer” (LYCA) randomised controlled trial.

Methods: Fifteen women treated with breast cancer surgery including ALND were recruited from participants in the LYCA trial. In this interrater reliability study, women were tested in 4 dynamic muscle tests by 2 physiotherapists at a Capital Hospital in Denmark. Intraclass correlation coefficients (ICCs) with 95% confidence intervals (CIs) was used to assess the relative reliability between raters. A Bland-Altman plot and limits of agreement were calculated to describe the absolute reliability.

Results: All 6 subtests displayed high interrater reliability. ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm) 0.91 (0.74-0.97). Cumulated interrater reliability for the test battery was very high (ICC = 0.99, 95% CI = 0.990-1.0). The absolute reliability of this study was considered high, and the absence of large shifts between mean and the line of 0 difference suggest no systematic bias that could influence clinical interpretation.

Conclusions: The dynamic muscle tests evaluated in this study had high interrater reliability and can be used reliably in women in the postoperative phase after breast cancer surgery with ALND.

A scoring system for predicting the risk of breast cancer-related lymphedema.

Li F1, Lu Q1, Jin S1, Zhao Q2, Qin X3, Jin S1, Zhang L1. Int J Nurs Sci. 2019 Dec 14;7(1):21-28.

OBJECTIVE:

We aimed to establish a scoring system to predict the risk of breast cancer-related lymphedema.

METHODS:

From April 2017 to December 2018, 533 patients who previously underwent surgery for breast cancer were enrolled in this cross-sectional study. Univariate analysis was performed to explore and define the risk factors. A scoring system was then established on the basis of odds ratio values in the regression analysis.

RESULTS:

The additive scoring system values ranged from 6 to 22. The receiver operating characteristic (ROC) curve of this scoring system showed a sensitivity and specificity of 83.3% and 57.3%, respectively, to predict the risk of lymphedema at a cut-off of 15.5 points; the area under the curve was 0.736 (95% confidence interval: 0.662-0.811), with χ 2 = 5.134 (P = 0.274) for the Hosmer-Lemeshow test.

CONCLUSIONS:

The predictive efficiency and accuracy of the scoring system were acceptable, and the system could be used to predict and screen groups at high risk for breast cancer-related lymphedema.

Economic evaluation of compression stockings for the prevention of venous leg ulcer recurrence in Ontario

Sandjar Djalalov, Shayan Sehatzadeh, David H Keast, William WL Wong. Journal of Wound CareVol. 29, No. 3

OBJECTIVE: Approximately between 1.5 and 3.0 per 1000 people are affected by venous leg ulcers (VLUs). The treatment and management of VLUs is costly and recurrence is a major concern. There is evidence that compression stockings can reduce the rate of re-ulceration compared with no compression. We present the first cost-effective analysis of compression stockings in preventing recurrence of VLUs from the perspective of the Ontario healthcare system.

METHOD: A cost-utility analysis with a five-year time horizon was conducted. Use of compression stockings was compared with usual care (no compression stockings). We simulated a hypothetical cohort of 65-year-old patients with healed VLUs, using a state-transition model. Model input parameters were obtained mainly from the published literature. We estimated quality-adjusted life years (QALYs) gained and direct medical costs. We conducted various sensitivity analyses.

RESULTS: Compared with usual care, compression stockings were associated with higher costs and increased QALYs. Cost-utility analysis showed that the incremental cost-effectiveness ratio of compression stockings was $23,864 per QALY gained compared with no compression stockings. The most influential drivers of cost-effectiveness were the utility value of healed VLUs, cost of stockings, number of stocking replacements, monthly prevention cost and the risk of VLU recurrence.

CONCLUSION: Compared with usual care, compression stockings were cost-effective in preventing VLUs, using a willingness-to-pay threshold of $50,000. These observations were consistent even when uncertainty in model inputs and parameters were considered.

Inter-observer and Intra-observer Variability in Volume Measurements of the Lower Extremity Using Perometer.

Reza C1, Nørregaard S1, Moffatt C1, Karlsmark T1. Lymphat Res Biol. 2020 Mar 10.

Background:

The swelling of the extremities seen in lymphedema can be measured with many different volumetric devices; however, many methods lack important characteristics including reproducibility and independence from the subjectivity and skill of the operator. The aim of this study was to validate the use of the Perometer® as a possible standard for volumetric measurement methods based on the inter-observer and intra-observer variability when using a standard method of Perometry®.

Methods and Results: Volumetric measurements were performed on 10 healthy test subjects by 5 individuals (the observers) who had been instructed in the measurement techniques to be used. The inter-observer variability was assessed by having the five observers measure all the test subjects both in the morning and in the early afternoon. The intra-observer variability was examined by having each observer measure all the 10 test subjects 4 times in a row in the aforementioned time frames. A data set was created using the measurements, allowing for the assessment of other parameters including variation of volume between the right and left leg and daily variation in swelling. Statistical measurements were performed using the Statistical Package for the Social Sciences (SPSS), from which it was determined that there was no statistically significant inter-observer (p-value 0.997) and intra-observer variation (p-value 0.995) based on a significance level of >5%. Furthermore, it was observed that a statistically significant difference in volume occurred in the leg volume during the day.

Conclusion: It was concluded that the use of the Perometer provides consistent measurements of volume independent of the observer and therefore appears to provide a candidate standard for volumetric measurements.

Lymphedema Surveillance and Patient-Reported Anxiety: Comparison Between Volumetric Assessment and Bioimpedance Analysis.

Stolker SA1, Stolker JM2, Radford DM3. Lymphat Res Biol. 2020 Mar 10.

Background: Lymphedema is a complication of breast cancer therapy associated with substantial anxiety. We designed a prospective, randomized study to assess the psychosocial impact of different surveillance methods for lymphedema.

Methods and Results: In this open-label study of 38 women undergoing breast cancer surgery, we screened for lymphedema using traditional volumetric measurements (circumferential readings from the wrist to the axilla) versus bioimpedance spectroscopy (BIS) using electric current. The primary outcome measure was total anxiety measured by the Beck Anxiety Inventory, a 21-item questionnaire administered at preoperative, 6-week, 3-month, and 6-month postoperative visits (range 0-63 points). Outcome metrics were compared after adjustment for baseline anxiety. There were no differences in clinical characteristics or cancer therapies between groups, except for more reoperation for positive surgical margins in the BIS patients (5% vs. 32%, p = 0.036). Baseline anxiety, depression, and associated medical therapies were similar as well. Only one woman in each group developed lymphedema during the study. Anxiety was higher in the BIS group at baseline (mean Beck score 12.2 vs. 7.2, p < 0.001), but anxiety levels gradually declined by the end of the 6-month study in both groups, with no differences in adjusted anxiety scores between the two groups at any time point during follow-up (all p = NS). Conclusions: In this pilot study of women scheduled for breast cancer surgery, most subjects reported mild anxiety at baseline, and anxiety levels fell during continued lymphedema surveillance visits. There was no difference in patient-reported anxiety when surveillance was performed using standard volumetric versus BIS measurements.

Effectiveness of a Home-based Head and Neck Lymphedema Management Program: A Pilot Study.

Yao T1, Beadle B2, Holsinger CF1, Starmer HM1. Laryngoscope. 2020 Feb 18

OBJECTIVE:

This study aimed to compare outcomes in patients with head and neck lymphedema receiving either a home-based lymphedema treatment program or a hybrid approach including both home-based treatment and regular clinical visits.

METHODS:

Outcomes were assessed in patients receiving head and neck lymphedema rehabilitation. Baseline measures of neck, submental, and facial edema were obtained and repeated following treatment. A home program was recommended for all patients, and those receiving hybrid care received the same recommendations as well as a visit with the lymphedema therapist for additional treatment. Their outcomes were compared using standard statistical analysis.

RESULTS:

Fifty consecutive individuals were included, 25 in each group. Adherence to at least 50% of recommended treatment was reported in 68% of those receiving home-based treatment and 84% of those receiving hybrid care. Significant improvement was demonstrated for 66% of patients. There was no statistically significant difference between treatment groups with regard to clinically significant improvement (P = .15). Patients receiving hybrid therapy demonstrated treatment advantages regarding facial edema (P = .037). Adherence to treatment was associated with clinical improvement (P = .047).

CONCLUSIONS:

Comparable benefits were observed regardless of whether patients had a home-based or hybrid lymphedema treatment approach. These data suggest a home-based treatment approach may be appropriate for patients unable to participate in clinical sessions. However, for patients with significant facial edema, a hybrid approach may be preferable. Adherence was associated with better outcomes. Given these findings, future investigations should consider strategies to improve adherence to optimize the outcomes lymphedema treatment.

LEVEL OF EVIDENCE:

3b Laryngoscope, 2020.

Effectiveness of modified complex decongestive physiotherapy for preventing lower extremity lymphedema after radical surgery for cervical cancer: a randomized controlled trial.

Wang X1, Ding Y2, Cai HY3, You J1, Fan FQ3, Cai ZF1, An P1. Int J Gynecol Cancer. 2020 Feb 26

BACKGROUND:

There is a lack of evidence in support of any prophylactic measure to prevent secondary lower extremity lymphedema after radical hysterectomy among patients with cervical cancer. This study aimed to determine the effectiveness of modified complex decongestive physiotherapy in reducing the risk of secondary lower extremity lymphedema after radical surgery.

METHODS:

A randomized single-blind clinical trial was conducted in 120 patients with cervical cancer who underwent laparoscopic radical hysterectomy with pelvic lymphadenectomy between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. Participants were randomly assigned to a modified complex decongestive physiotherapy intervention group (n=60) or control group (n=60). The intervention group received a modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education. The control group only received a health education program. The main outcome was the incidence of secondary lower extremity lymphedema.

RESULTS:

A total of 117 patients with cervical cancer completed a 1-year follow-up. Twenty-eight (23.9%) patients developed secondary lower extremity lymphedema (20 (34.5%) patients in the control group and 8 (13.6%) in the intervention group). The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30 (95% CI 0.12 to 0.75). The median percentage of excess volume was significantly less in the intervention group (2.1%, IQR 0.5-3.4%) than in the control group (2.96%, IQR 1.1-4.98%); (p=0.042). The mean (SD) onset time of lymphedema was 8 (2.00) months vs 4.6 (2.82) months in the intervention and control groups, respectively (p=0.004).

CONCLUSIONS:

This randomized trial showed that modified complex decongestive physiotherapy is effective for preventing lower extremity lymphedema in patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy.

Lay Caregivers Education in Multicomponent Compression Bandaging in Obese Patients with Lower Limb Edema: A Case-Control Pilot Study.

Gradalski T1, Ochalek K1,2. Lymphat Res Biol. 2020 Mar 4.

Background: A report on the usefulness of the instruction of lay carers in multilayer short-stretch compression bandaging within the initial intensive phase physical treatment of mixed-etiology chronic lower limb edema.

Methods and Results: In a group of adult obese patients (including 24 females) with venous insufficiency and chronic bilateral lower limb edema, and without a history of physical therapy, 20 (ambulatory managed) were bandaged once daily (four layers, short stretch with cotton tube, and foam padding underneath) for 3 weeks (Monday-Friday) by skilled physiotherapists, and in 20 cases (education group, EG), the patients’ lay carers were educated by these physiotherapists according to the same regime during one session. The outcome measures included limb volume (the method of circumference measurement with a tape at 4 cm intervals) after 1, 3, and 6 months, the time to reach the maintenance phase, the frequency of complementary bandaging during this phase, and the sense of self-efficacy (General Self-Efficacy scale, GSEs). No significant differences were noted between the two groups in the baseline measurements of age, body mass, and limb volume. The carers were able to apply compression bandages in all cases during the observation period. The time to reach the maintenance phase was longer in EG (6 vs. 1 weeks; p < 0.001). A similar median reduction in edema volume was observed at the end of the bandaging period, which continued for 3 and 6 months. It was only in EG that further improvement between 1 and 3 months was observed (p = 0.008). All participants represented an equally high optimistic sense of personal competence (GSEs). Conclusions: The instruction of lay carers in bandaging may provide a simple clinically effective solution for lower limb edema management, thus lowering its costs.

Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial.

Omidi Z1, Kheirkhah M2, Abolghasemi J3, Haghighat S4. Qual Life Res. 2020 Mar 9.

BACKGROUND:

Breast cancer-related lymphedema (BCRL) and its associated symptoms harm the quality of life (QoL) of cancer survivors and can stimulate fear of cancer recurrence (FCR). Self-management education for lymphedema has been introduced as an effective method in controlling FCR. This study investigates the effect of lymphedema group-based education compared to the social network-based and control group on QoL and FCR in breast cancer patients.

METHODS:

This three-arm clinical trial studied 105 patients with breast cancer-related lymphedema referred to Seyed_Khandan rehabilitation center. Sampling was done by random allocation method in blocks of 3 with 35 subjects in each group. All subjects received routine lymphedema treatments. The group-based education (GE) and social network-based education (SNE) groups received self-management education in the clinic and Telegram™ messenger channel, respectively. Impairment in QoL and mean score of FCR were assessed before, immediately after, and three months after the intervention by using the Persian version of Lymphedema Life Impact Scale (LLIS) and Fear of Progression Questionnaire-Short Form (FoPQ-SF), respectively. Mixed-model ANOVA was applied for statistical analysis.

RESULTS:

There was a significant time effect on total LLIS (P = 0.007), psychosocial (P = 0.038) and functional (P = 0.024) subscale changes in three groups of study. Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017). The multicomparison results illustrated that the main effect of time, the main effect of group, and interaction of them on the mean score of FCR were P = 0.084, P = 0.380, and P = 0.568, respectively.

CONCLUSION:

Despite no significant reduction in the FCR score, results showed the improvement of most QoL aspects after three months of intervention. Although the social network-based education method was effective, the group-based education method was more beneficial. Applying these educational methods in lymphedema treatment protocols needs cost-effectiveness studies.

Comparison of the short-term effects of hyperbaric oxygen therapy and complex decongestive therapy on breast cancer-related lymphedema: A pilot study.

Koo JH1, Song SH1, Oh HS2, Oh SH3. Medicine (Baltimore). 2020 Mar;99(11)

Although there have been some reports that hyperbaric oxygen therapy (HBOT) is effective in treating breast cancer-related lymphedema (BCRL), controversy regarding its therapeutic effects remains.We sought to evaluate the efficacy of HBOT in addition to conventional complex decongestive therapy (CDT) for BCRL.A prospective observational study was conducted on 10 patients with BCRL. After screening, the subjects were stratified into a CDT-only group and a CDT and HBOT combination (CDT-HBOT) group. All patients received a total of 10 treatments over 2 weeks. Changes in the circumference of the upper limbs, quality-of-life questionnaire results, and bioelectrical impedance values were compared between the 2 groups.Between both groups, there were no significant differences in demographic or clinical characteristics and in the quality-of-life outcomes for lymphedema of the limbs. The parameters measured by bioimpedance spectroscopy showed more significant improvements in the CDT-HBOT group than in the CDT-only group.In patients with BCRL, HBOT may be recommended as an adjunct treatment to the existing therapies.

Lymphedema: A Practical Approach and Clinical Update.

Bittar S1, Simman R2, Lurie F3. Wounds. 2020 Mar;32(3):86-92.

The lymphatic system is arguably the most neglected bodily system. As a result, its contribution to human health and disease is not well understood. In this review, the clinical approaches based on new knowledge and developments of the lymphatic system are covered. The lymphatic system has 3 major functions: (1) the preservation of fluid balance; (2) a nutritional function, as intestinal lymphatics are responsible for fat absorption; and (3) host defense. Lymph vessels return the capillary ultrafiltrate and escaped plasma proteins from most tissues back, ultimately, to the blood circulation. Hence, lymphatics are responsible for maintaining tissue (and plasma) volume homeostasis. Impaired lymph drainage results in peripheral edema (lymphedema) and may have more far-reaching effects on cardiovascular disease, in particular hypertension and atherosclerosis. Lymphatics have an important immune surveillance function, as they represent the principal route of transport from tissues for antigen and immune cells. Intestinal lymphatics (lacteals) are responsible for most fat absorption, first documented by Gaspare Aselli in 1627, when the lymphatic system was discovered. A relationship between fat and lymphatics may exist well beyond the gut alone. Fat deposition is a defining clinical characteristic of lymphedema. Suction-assisted lipectomy of lymphedema has shown the swelling is not just fluid but is dominated by fat. Lymphatics are the preferred route for the metastatic spread of cancer. Accordingly, the lymphatic system may be important for defense against cancer by generating immune responses to malignant cell antigens. Preventing lymphatic entry and propagation of malignant metastasis would effectively render the cancer nonfatal. As one can see, the lymphatic circulation is fundamentally important to cardiovascular disease, infection and immunity, cancer, and, in all likelihood, obesity – 4 of the major challenges to health care in the 21st century.