Sheila H. Ridner

Study finds that it is essential to screen for lymphedema. Early detection and intervention improves outcomes.

Background: Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored. Methods and Results: We enrolled newly diagnosed nonmetastatic breast cancer patients for surveillance up to 36 months postoperatively. Upon detection of S-BCRL, a 28-day compression intervention was initiated. Data were obtained through physical examination/measurement and self-report instruments: skin examination, Lymphedema Symptom Intensity and Distress Survey-Arm, and Functional Assessment of Cancer Therapy General (FACT-G), Breast (FACT-B), and FACT-B+4. Improvements with intervention were observed in the proportion of patients reporting symptom scores ≥3 in function (Cohen's d = −0.46, p < 0.01), in biobehavioral (Cohen's d = −0.30, p < 0.05), maximum number of skin conditions (Cohen's d = −0.34, p < 0.05. 3), FACT-B (Cohen's d = 0.52, p < 0.01), and FACT-B + four (Cohen's d = −0.42, p < 0.01). At the study endpoint, compared with those who did not progress, chronic breast cancer-related lymphedema (C-BCRL) progressing patients had higher overall symptom scores ( p = 0.037), more skin conditions ( p = 0.009), and lower total FACT-G and FACT-B scores ( p < 0.05). At the time of S-BCRL, detection of greater BIS unit change correlated with higher symptom, skin condition, and QoL values. Greater whole-arm volume change correlated with higher FACT-B+4 scores (all p < 0.05). Conclusions: Prospective surveillance, symptom assessment, and compression intervention promote low progression rates from S-BCRL to C-BCRL and as such reduce symptom burden. This closed study is registered with ClinicalTrials.gov NCT02167659

The researchers’ aims for this preliminary study was to develop an instrument, guided by the Theory of Health-related Family Quality of Life, to measure health-related family quality of life (HR-FQoL) as perceived by women with cancer. The researchers used a two phase design for instrument development: (1) establishing face validity of a 38-item instrument with an expert panel and patient review, and (2) focusing on the internal structure and construct validity of the instrument with responses from female patients (N = 236) with a cancer diagnosis (breast, gynecologic). The researchers identified a final 25-item HR-FQoL instrument with four sub-scales that each captured multiple concepts within the Theory of HR-FQoL. The resulting instrument maybe used by researchers and clinicians to assess various aspects of health-related family quality of life among female breast and gynecological cancer survivors.

Background: Lack of reliable and valid tools significantly impacts early identification and timely treatment of lymphedema and fibrosis (LEF) in the head and neck cancer population. To address this need, we developed and reported a patient-reported outcome measure (Head and Neck Lymphedema and Fibrosis Symptom Inventory [HN-LEF SI]). This article reports the construct validity (convergent and divergent validity) testing of the tool. Materials and Methods: A prospective, longitudinal, instrument validation study was conducted in patients with a newly diagnosed oral cavity or oropharyngeal cancer. Participants completed the HN-LEF SI and six carefully selected self-report measures at pretreatment, end-of-treatment, and every 3 months up to 12 months after treatment. Spearman correlations were used. Results: A total of 117 patients completed the study. Patterns of correlations of the HN-LEF SI scores with the established self-report measure scores were consistent with expected convergent and divergent validity. Conclusion: Evidence from this work supports the construct validity of the HN-LEF SI.

Background: This study compared rates of progression to chronic breast cancer-related lymphedema (defined as ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM). Methods and Results: This stratified, randomized, international trial enrolled new breast cancer patients undergoing: mastectomy/partial mastectomy, axillary treatment (dissection, sentinel lymph node biopsy [SLNB] >6 nodes or radiation), radiation therapy (chest wall/breast, supraclavicular fossa), or taxane-based chemotherapy. Following postsurgery eligibility reassessment, centralized, 1:1 randomization to prospective surveillance by BIS or TM occurred. S-BCRL detection triggered a 4-week, 12-hour per day, compression sleeve, and gauntlet intervention. The primary outcome ( n = 209), rates of postintervention progression to CDP, was assessed over 3 years. Between June 24, 2014 and September 11, 2018, 1200 patients were enrolled, 963 randomized (BIS n = 482; TM n = 481) and 879 analyzed (BIS n = 442; TM n = 437). Median follow-up was 32.9 months (interquartile range = 22, 35). BIS patients triggered an intervention at a lower rate than TM patients (20.1%, n = 89 vs. 27.5%, n = 120, p = 0.011). Median months to trigger were longer with BIS than TM (9.7; 95% confidence interval [CI], 8.2–12.6 vs. 3.9; 95% CI, 2.8–4.5, p = 0.001). Overall, 14.4% ( n = 30) progressed post-intervention, with reduced likelihood for BIS patients than TM patients (7.9%, n = 7 vs. 19.2%, n = 23; relative risk = 0.41; 95% CI, 0.13–0.81; absolute reduction 11.3%; 95% CI, 2.3–20.3; p = 0.016). Conclusions: Compared to TM, BIS provides a more precise identification of patients likely to benefit from an early compression intervention. Clinical Trial Registration number: NCT02167659.

Background: To evaluate risk factors (treatment‐related, comorbidities, and lifestyle) for breast cancer–related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL.Methods: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L‐Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni‐corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance.Results: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane‐based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk.Conclusions: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane‐based chemotherapy, RNI, body mass index >30, and rurality increased risk.

Background: This study compared rates of progression to chronic breast cancer-related lymphedema (defined as a ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy (CDP)) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM). Methods and Results: This stratified, randomized, international trial enrolled new breast cancer patients undergoing: mastectomy/partial mastectomy, axillary treatment (dissection, sentinel lymph node biopsy >6 nodes or radiation), radiation therapy (chest wall/ breast, supraclavicular fossa), or taxane-based chemotherapy. Following post-surgery eligibility reassessment, centralized, 1:1 randomization to prospective surveillance by BIS or TM occurred. S-BCRL detection triggered a 4-week, 12-hour per day, compression sleeve and gauntlet intervention. The primary outcome (n=209), rates of post-intervention progression to CDP, were assessed over three years. Between June 24, 2014 and September 11, 2018, 1,200 patients were enrolled, 963 randomized (BIS n=482;TM n=481) and 879 analyzed (BIS n=442;TM n=437). Median follow-up was 32.9 months (IQR=22,35). BIS patients triggered an intervention at a lower rate than TM patients (20.1%, n=89 vs 27.5%, n=120, p = 0.011). Median months to trigger was longer with BIS than TM (9.7; 95%CI,8.2-12.6 vs 3.9; 95%CI,2.8-4.5, p = 0.001). Overall, 14.4%(n=30) progressed post-intervention, with reduced likelihood for BIS patients than TM patients (7.9%, n=7 vs 19.2%, n=23; RR=0.41; 95%CI,0.13-0.81; absolute reduction 11.3%; 95%CI,2.3%-20.3%; p = 0.016). Conclusions: As compared to TM, BIS provides a more precise identification of patients likely to benefit from an early compression intervention. Condensed This stratified, multi-site, international trial enrolled newly diagnosed breast cancer patients, randomized them to prospective surveillance by bioimpedance spectroscopy (BIS) or tape measurement (TM), and screened them for lymphedema development at frequent intervals for three years after surgery. When subclinical lymphedema was detected a 4-week, 12-hour per day, compression sleeve and gauntlet intervention was implemented. Overall, 14.4% (n=30) progressed post-intervention to chronic lymphedema, with reduced likelihood for BIS patients than TM patients (7.9%, n=7 vs 19.2%, n=23; RR=0.41; 95%-CI,0.13-0.81; absolute reduction 11.3%; 95%-CI,2.3%-20.3%; p = 0.016). BIS best supported intervention success for prevention of chronic lymphedema compared to TM.

This RCT and mixed-methods study examined the difference between two groups receiving the following interventions: (1) brief manual standardized stress acupuncture (MSSA) combined with an abbreviated Cognitive Behavioral Therapy (ACBT) versus (2) ACBT alone. Three study aims: Aim (1): Insomnia Severity Index (ISI) and Pittsburg Sleep Quality Index (PSQI) scores were analyzed using descriptive summaries, linear regression, and reliable change index (RCI). Aim (2): Journal entries were analyzed using content analysis. Aim (3): Acupuncture Expectancy Scale (AES) scores were analyzed using paired t-test and RCI. Aim (1): Both groups demonstrated similar improvements in the ISI scores (p = .480). Aim (2): The ACBT/MSSA group reported greater benefits in sleep and in other life areas including mental, physical, and social functioning. Aim (3): The AES showed that 21.6% had a clinically meaningful increase in expectations in the effect of acupuncture for stress (p = .965). The study was registered in ClinicalTrials.gov (NCT04031365) at https://clinicaltrials.gov/ct2/show/NCT04031365 on July 24, 2019.

Background: A comparison of symptom prevalence, intensity, and distress for participants with truncal lymphedema, head and neck lymphedema, and no lymphedema identified a need for a truncal-specific, lymphedema-related symptom assessment tool and a revision of the Lymphedema Symptom Intensity and Distress Survey—Head and Neck (LSIDS-H&N). The purpose of this study was to institute the development of the Lymphedema Symptom Intensity and Distress Survey—Truncal (LSIDS-T) and revise the LSIDS-H&N. Methods and Results: A comprehensive midline measure and subsequent series of analyses were used to develop the LSIDS-T and revise the initial LSIDS-H&N. Participants included 97 without lymphedema, 82 with truncal lymphedema, and 72 with head and neck lymphedema. Cluster analysis for the LSIDS-T resulted in five clusters with a total of 21 items. Cluster analysis for the LSIDS-H&N resulted in seven clusters with a total of 31 items. Key correlations in expected directions were found with the validated measures for both surveys, and correlations with the Marlowe Crown Social Desirability Scale did not indicate issues with social desirability of response. Conclusion: The 24-item LSIDS-T and the 31-item revised LSIDS-H&N v.2 are promising additions to the suite of other LSIDS measures for use in clinical environments.