Patient Experience of Photobiomodulation Therapy in Head and Neck Chronic Lymphedema.

Purpose: Lymphedema is a common late effect of head and neck cancer treatment that causes various symptoms, functional impairment, and poor quality of life. We completed a pilot, prospective, single-arm clinical trial to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema. In this study, we report patients' perceived treatment experience of PBM therapy and provide suggestions to better understand head and neck cancer survivors' experience of PBM therapy. Methods: Head and neck cancer patients who underwent PBM therapy completed face-to-face semi-structured interviews. Interviews were audio-recorded and then transcribed verbatim. Qualitative content analysis was used to analyze the transcriptions from the interviews. Results: Among 12 participants who consented for the study, 11 (91.7%) completed the PBM therapy. Participants described positive experiences and unique benefits about the PBM therapy, for example, decreased swelling, reduced tightness, increased range of motion, increased saliva production, and improved ability to swallow. Some participants (n = 5, 45.5%) delineated challenges related to traffic, travel time, and distance from study location. Many participants proposed suggestions for future research on PBM therapy, for example, research on internal edema and its relationship with swallowing, and indicated patients with severe lymphedema and fibrosis may be more likely to benefit. Conclusions: Findings from this study suggested the potential benefits of PBM therapy in treatment of chronic head and neck lymphedema. Rigorously designed clinical trials are needed to evaluate the effect of PBM therapy for head and neck cancer-related lymphedema. Trial Registration Number and Date of Registration: ClinicalTrials.gov Identifier: NCT03738332; date of registration: November 13, 2018.

Knowledge regarding cancer-related fatigue: a survey of physical therapists and individuals diagnosed with cancer.

BACKGROUND: Cancer-related fatigue (CRF) is a common side effect and remains under-diagnosed. Screening of CRF by physical therapists (PTs) and patient perspectives of their experiences has not been comprehensively examined. PURPOSE: To survey PTs to understand the frequency of CRF screening, and to assess the knowledge and experiences of survivors as it relates to CRF. METHODS: Two separate electronic surveys developed by the authors were distributed. One targeted oncology PTs, the other for adult survivors of cancer. RESULTS: Of the 199 PT respondents, 36% reported screening for CRF at every encounter. Screening included interviews (46%) and/or standardized questionnaires (37%). The most common barriers to receiving treatment for CRF was lack of physician referrals and time constraints. Of patient responses (n = 61), 84% reported CRF as an important ongoing issue; 77% reported that they initiated the discussion about CRF with their provider, and 23% reported being told there were treatment options for CRF. CONCLUSION: CRF is common among cancer survivors. However, consistent screening by PTs is lacking. Patients with CRF frequently initiated the conversation with their providers because of symptoms and many patients were not told of treatment options. These findings represent a substantial gap in clinical practice regarding CRF screening and management.

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies.

The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Screening and Assessment of Cancer-Related Fatigue: A Clinical Practice Guideline for Health Care Providers.

Cancer-related fatigue (CRF) is the most common side effect of cancer treatment. Regular surveillance is recommended, but few clinical practice guidelines transparently assess study bias, quality, and clinical utility in deriving recommendations of screening and assessment methods. The purpose of this clinical practice guideline (CPG) is to provide recommendations for the screening and assessment of CRF for health care professions treating individuals with cancer. Following best practices for development of a CPG using the Appraisal of Guidelines for Research and Evaluation (AGREE) Statement and Emergency Care Research Institute (ECRI) Guidelines Trust Scorecard, this CPG included a systematic search of the literature, quality assessment of included evidence, and stakeholder input from diverse health care fields to derive the final CPG. Ten screening and 15 assessment tools supported by 114 articles were reviewed. One screen (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 Core Questionnaire) and 3 assessments (Piper Fatigue Scale-Revised, Functional Assessment of Chronic Illness Therapy-Fatigue, and Patient Reported Outcome Measurement Information System [PROMIS] Fatigue-SF) received an A recommendation ("should be used in clinical practice"), and 1 screen and 5 assessments received a B recommendation ("may be used in clinical practice"). Health care providers have choice in determining appropriate screening and assessment tools to be used across the survivorship care continuum. The large number of tools available to screen for or assess CRF may result in a lack of comprehensive research evidence, leaving gaps in the body of evidence for measurement tools. More research into the responsiveness of these tools is needed in order to adopt their use as outcome measures. IMPACT: Health care providers should screen for and assess CRF using one of the tools recommended by this CPG.

Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study.

PURPOSE: Lymphedema is a common debilitating late effect among patients post-head and neck cancer (HNC) treatment. Head and neck lymphedema was associated with symptom burden, functional impairment, and decreased quality of life. The objective of this study was to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema, symptom burden, and neck range of motion among HNC survivors. METHODS: This was a single-arm, pre- and post-design clinical trial. Eligible patients included those with lymphedema after completion of complete decongestive therapy (CDT) and 3 to 18 months after completion of cancer therapy. The intervention included PBM therapy 2 times a week for 6 weeks for a total of 12 treatments. Lymphedema, symptom burden, and neck range of motion were measured at baseline, end-of-intervention, and 4-week post-intervention. RESULTS: Of the 12 patients enrolled in the study, 91.7% (n = 11) completed the study intervention and assessment visits, and no adverse events were reported. When comparing the baseline to 4-week post-intervention, we found statistically significant improvements in the severity of external lymphedema, symptom burden, and neck range of motion (all P < .05). CONCLUSION: PBM therapy was feasible and potentially effective for the treatment of head and neck lymphedema. Future randomized controlled trials are warranted to examine the efficacy of PBM therapy for HNC-related lymphedema. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03738332; date of registration: November 13, 2018.

Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity.

OBJECTIVE: The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer-related lymphedema, for use in the context of outcome evaluation in clinical trials. DESIGN: Blinded repeated measures observational study. SETTING: Outpatient research laboratory. PARTICIPANTS: Breast cancer survivors with and without lymphedema (N=71). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool. RESULTS: Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score. CONCLUSIONS: The CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.

Exercise in patients with lymphedema: a systematic review of the contemporary literature.

BACKGROUND: Controversy exists regarding the role of exercise in cancer patients with or at risk for lymphedema, particularly breast. We conducted a systematic review of the contemporary literature to distill the weight of the evidence and provide recommendations for exercise and lymphedema care in breast cancer survivors. METHODS: Publications were retrieved from 11 major medical indices for articles published from 2004 to 2010 using search terms for exercise and lymphedema; 1,303 potential articles were selected, of which 659 articles were reviewed by clinical lymphedema experts for inclusion, yielding 35 articles. After applying exclusion criteria, 19 articles were selected for final review. Information on study design/objectives, participants, outcomes, intervention, results, and study strengths and weaknesses was extracted. Study evidence was also rated according to the Oncology Nursing Society Putting Evidence Into Practice® Weight-of-Evidence Classification. RESULTS: Seven studies were identified addressing resistance exercise, seven studies on aerobic and resistance exercise, and five studies on other exercise modalities. Studies concluded that slowly progressive exercise of varying modalities is not associated with the development or exacerbation of breast cancer-related lymphedema and can be safely pursued with proper supervision. Combined aerobic and resistance exercise appear safe, but confirmation requires larger and more rigorous studies. CONCLUSIONS: Strong evidence is now available on the safety of resistance exercise without an increase in risk of lymphedema for breast cancer patients. Comparable studies are needed for other cancer patients at risk for lymphedema. IMPLICATIONS FOR CANCER SURVIVORS: With reasonable precautions, it is safe for breast cancer survivors to exercise throughout the trajectory of their cancer experience, including during treatment.

Weight lifting in patients with lower-extremity lymphedema secondary to cancer: a pilot and feasibility study.

OBJECTIVE: To assess the feasibility of recruiting and retaining cancer survivors with lower-limb lymphedema into an exercise intervention study. To develop preliminary estimates regarding the safety and efficacy of this intervention. We hypothesized that progressive weight training would not exacerbate leg swelling and that the intervention would improve functional mobility and quality of life. DESIGN: Before-after pilot study with a duration of 5 months. SETTING: University of Pennsylvania. PARTICIPANTS: Cancer survivors with a known diagnosis of lower-limb lymphedema (N=10) were directly referred by University of Pennsylvania clinicians. All 10 participants completed the study. INTERVENTION: Twice weekly slowly progressive weight lifting, supervised for 2 months, unsupervised for 3 months. MAIN OUTCOME MEASURES: The primary outcome was interlimb volume differences as measured by optoelectronic perometry. Additional outcome measures included safety (adverse events), muscle strength, objective physical function, and quality of life. RESULTS: Interlimb volume differences were 44.4% and 45.3% at baseline and 5 months, respectively (pre-post comparison, P=.70). There were 2 unexpected incident cases of cellulitis within the first 2 months. Both resolved with oral antibiotics and complete decongestive therapy by 5 months. Bench and leg press strength increased by 47% and 27% over 5 months (P=.001 and P=.07, respectively). Distance walked in 6 minutes increased by 7% in 5 months (P=.01). No improvement was noted in self-reported quality of life. CONCLUSIONS: Recruitment of patients with lower-limb-lymphedema into an exercise program is feasible. Despite some indications that the intervention may be safe (eg, a lack of clinically significant interlimb volume increases over 5 mo), the unexpected finding of 2 cellulitic infections among the 10 participants suggests additional study is required before concluding that patients with lower-extremity lymphedema can safely perform weight lifting.