Axillary Treatment and Chronic Breast Cancer-Related Lymphedema: Implications for Prospective Surveillance and Intervention From a Randomized Controlled Trial.

PURPOSE: The PREVENT randomized trial assessed progression to chronic breast cancer-related lymphedema (cBCRL) after intervention triggered by bioimpedance spectroscopy (BIS) or tape measurement (TM). This secondary analysis identifies cBCRL risk factors on the basis of axillary treatment. METHODS: Between June 2014 and September 2018, 881 patients received sentinel node biopsy (SNB; n = 651), SNB + regional node irradiation (RNI; n = 58), axillary lymph node dissection (ALND; n = 85), or ALND + RNI (n = 87). The primary outcome was the 3-year cBCRL rate requiring complex decongestive physiotherapy (CDP). RESULTS: After a median follow-up of 32.8 months (IQR, 21-34.3), 69 of 881 patients (7.8%) developed cBCRL. For TM, 43 of 438 (9.8%) developed cBCRL versus 26 of 443 (5.9%) for BIS (P = .028). The 3-year actuarial risk of cBCRL was 4.4% (95% CI, 2.7 to 6.1), 4.2% (95% CI, 0 to 9.8), 25.8% (95% CI, 15.8 to 35.8), and 26% (95% CI, 15.3 to 36.7). Rural residence increased the risk in all groups. For SNB, neither RNI (SNB, 4.1% v SNB + RNI, 3.4%) nor taxane (4.4%) increased cBCRL, but risk was higher for patients with a BMI of ≥30 (6.3%). For SNB + RNI, taxane use (5.7%) or supraclavicular fossa (SCF) radiation (5.0%) increased cBCRL. For ALND patients, BMI ≥25 or chemotherapy increased cBCRL. For ALND + RNI, most patients received SCF radiation and taxanes, so no additional risk factors emerged. CONCLUSION: The extent of axillary treatment is a significant risk factor for cBCRL. Increasing BMI, rurality, SCF radiation, and taxane chemotherapy also increase risk. These results have implications for a proposed risk-based lymphedema screening, early intervention, and treatment program.

Development and preliminary validation of a health-related family quality of life instrument.

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.

Subjective Cognition is Related to Patient-Reported Symptom Distress and Work Productivity Among Liver Transplant Recipients.

Cognitive decline may prevent liver transplant (LT) recipients from staying healthy and independent. This study examined associations of objective and subjective, rated by LT recipients and caregivers, cognitive decline with patient-reported physical and psychological symptom distress, ability to perform household tasks, and workplace productivity among LT recipients. Sixty pairs of LT recipients and caregivers participated in this cross-sectional study. Subjective cognition was measured by the Everyday Cognition. Objective cognition was assessed with four cognitive tests, including the Repeatable Battery for the Assessment of Neuropsychological Status. Patient-reported outcomes were assessed with the Rotterdam Symptom Checklist-Modified, Profile of Mood States-Short Form, Creative Therapy Consultants Homemaking Assessment, and Work Limitations Questionnaire. Linear regression analyses related objective and subjective cognition to the patient-reported outcomes. While objective cognitive decline was not associated with any patient-reported outcomes, subjective cognitive decline was significantly associated with the outcomes. Higher LT recipient self-rated cognitive decline was associated with higher physical symptom distress ( ß = 0.30, p = 0.006) and workplace productivity loss ( ß = 14.85, p < 0.0001). Higher caregiver-rated cognitive decline was associated with lower household tasks performance ( ß = -18.55, p = 0.015). Findings suggest to consider subjective cognition when developing an individualized post-transplant care plan.

Qualitative similarities and distinctions between participants' experiences with a yoga intervention and an attention control.

PURPOSE: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer. METHODS: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory. RESULTS: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST. CONCLUSIONS: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious.

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life 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.

Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention.

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.

Validity Testing of the Head and Neck Lymphedema and Fibrosis Symptom Inventory.

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.

A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention.

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.

Subjective Cognition Reported by Caregivers Is Correlated With Objective Cognition in Liver Transplant Recipients.

Objective cognitive assessments, a gold standard diagnostic tool for cognitive impairment, may not be feasible in busy liver transplantation (LT) practice because they are often time consuming. This study determined whether subjective cognition, patients' self-ratings and/or caregivers' ratings of patients' cognition, reflects objective cognition in LT recipients. A convenience sample of 60 adult LT recipients and their caregivers, recruited at a single transplant center, participated in this cross-sectional descriptive study. Subjective cognition (ie, recipient self-rated and caregiver rated) was measured using the Everyday Cognition (ECog; global and 6 domain scores). Objective global and domain-specific cognition of recipients was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test parts A and B, Digit Span Backward, and Rey-Osterrieth Complex Figure. Agreement between LT recipients' ECog scores and those of their caregivers was fair to moderate (intraclass correlation coefficient = 0.48 for global score, 0.35-0.56 for domain scores). Significant, albeit rather weak, correlations were found between subjective and objective scores. Recipients' ECog visuospatial abilities scores were correlated with Rey-Osterrieth Complex Figure scores (rs  = -0.39; P = 0.007), whereas caregivers' ECog global, attention, visuospatial abilities, and organization scores were, respectively, correlated with the scores of RBANS global (rs  = -0.33; P = 0.04) and attention (rs  = -0.46; P = 0.005), Rey-Osterrieth Complex Figure (Copy; rs  = -0.34; P = 0.03), and Trail Making Test part A (rs  = 0.31; P = 0.049). The findings suggest that caregivers may estimate LT recipients' cognition better than recipients themselves. Caregivers may provide supplemental information that could be useful for clinicians when considering the cognitive functioning of LT recipients.

A Randomized Controlled Pilot Study of Yoga Skills Training Versus an Attention Control Delivered During Chemotherapy Administration.

CONTEXT: It is important to address fatigue and co-occurring symptoms during chemotherapy to preserve quality of life in patients with gastrointestinal (GI) cancer. OBJECTIVE: To conduct a randomized controlled pilot study of a Yoga Skills Training (YST) intervention compared to an attention control (AC) among adults diagnosed with GI cancer. METHODS: YST consisted of four 30-minute sessions delivered individually during chemotherapy plus home practice. AC provided empathic attention plus home diaries. Patient-reported (PROMIS T-score) assessments of fatigue, depressive symptoms, sleep disturbances, and psychological stress (Perceived Stress Scale) were collected at chemotherapy visits: baseline, Week 8, Week 10 and Week 14, and analyzed using a mixed effects model. Inflammatory cytokines were assessed at baseline and Week 10. RESULTS: Forty-four of 77 adults approached agreed to participate (57%; YST n = 23; AC n = 21). Participants' mean age was 58 years and 48% were men. Participants randomized to YST reported a larger decline in fatigue (-2.4 difference, d = 0.30) and depressive symptoms (-2.5 difference, d = 0.30) than AC participants from baseline to Week 10 and sleep disturbances at Week 8 (-3.9 difference, d = 0.50). Differences in magnitude of change in symptoms were consistent with or exceeded a minimally important difference. Psychological stress decreased more in the AC at Week 10 (d = 0.30). Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC. CONCLUSION: YST showed promise for improving fatigue, depressive symptoms, sleep disturbances, and inflammation. YST is also feasible and reaches patients underrepresented in yoga research (i.e., GI cancer, men), thus warranting further examination.

Perceived Effects of Neuropsychiatric Symptoms on Functional Status in Early-stage Huntington Disease.

Neuropsychiatric symptoms in Huntington disease (HD) are commonly encountered, but their effects on functional status are poorly understood. In this qualitative study guided by the Theory of Unpleasant Symptoms, 15 HD patients and caregivers completed semi-structured interviews regarding perceived effects of neuropsychiatric symptoms on functional status. Physical, cognitive, and social functional effects were reported, with negative effects on daily activities and social withdrawal being reported by the greatest number of subjects. Participants also reported improved function with intervention for neuropsychiatric symptoms. This study provides a novel description of the lived experiences of HD patients with neuropsychiatric symptoms.

Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members: A Randomized Controlled Trial.

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.

Improved Parent-Child Communication following a RCT Evaluating a Legacy Intervention for Children with Advanced Cancer.

Although legacy-building is a priority for quality palliative care, research has rarely examined effects of legacy interventions in children, particularly their impact on parent-child communication.We examined the impact of a web-based legacy intervention on parent-child communication. We hypothesized that compared to usual care, legacy-making would improve quality of parent-child communication.Between 2015 and 2018, Facebook advertisements were used to recruit families of children (ages 7-17) with relapsed/refractory cancer. Parent-child dyads were randomly assigned to the intervention or usual care group. The intervention website guided children to create digital storyboards over 2 weeks by directing them to answer legacy questions about themselves and upload photographs, videos, and music. Families received a copy of the child's final digital story. Children and parents completed the Parent-Adolescent Communication Scale pre- (T1) and post-intervention (T2). Linear regressions tested for differences in change from T1 to T2 between the groups controlling for T1 values using an alpha of p < .05. Intervention effects were measured using Cohen's d. Ninety-seven parent-child dyads were included for analysis. Changes in parent-child communication were not statistically significantly different between the groups, yet meaningful intervention effects were observed. The strongest effects were observed for improving father-child communication (Cohen's d = -0.22-0.33). Legacy-making shows promise to facilitate improved parent-child communication, particularly for fathers. Future studies should include fathers and measure expression of feelings and parent-child interaction. Providers should continue to facilitate family communication for children with advanced disease and realize that legacy interventions may impact mother-child versus father-child communication differently.

Implementation strategies in the context of medication reconciliation: a qualitative study.

BACKGROUND: Medication reconciliation (MedRec) is an important patient safety initiative that aims to prevent patient harm from medication errors. Yet, the implementation and sustainability of MedRec interventions have been challenging due to contextual barriers like the lack of interprofessional communication (among pharmacists, nurses, and providers) and limited organizational capacity. How to best implement MedRec interventions remains unclear. Guided by the Expert Recommendations for Implementing Change (ERIC) taxonomy, we report the differing strategies hospital implementation teams used to implement an evidence-based MedRec Toolkit (the MARQUIS Toolkit). METHODS: A qualitative study was conducted with implementation teams and executive leaders of hospitals participating in the federally funded "Implementation of a Medication Reconciliation Toolkit to Improve Patient Safety" (known as MARQUIS2) research study. Data consisted of transcripts from web-based focus groups and individual interviews, as well as meeting minutes. Interview data were transcribed and analyzed using content analysis and the constant comparison technique. RESULTS: Data were collected from 16 hospitals using 2 focus groups, 3 group interviews, and 11 individual interviews, 10 sites' meeting minutes, and an email interview of an executive. Major categories of implementation strategies predominantly mirrored the ERIC strategies of "Plan," "Educate," "Restructure," and "Quality Management." Participants rarely used the ERIC strategies of finance and attending to policy context. Two new non-ERIC categories of strategies emerged-"Integration" and "Professional roles and responsibilities." Of the 73 specific strategies in the ERIC taxonomy, 32 were used to implement the MARQUIS Toolkit and 11 new, and non-ERIC strategies were identified (e.g., aligning with existing initiatives and professional roles and responsibilities). CONCLUSIONS: Complex interventions like the MARQUIS MedRec Toolkit can benefit from the ERIC taxonomy, but adaptations and new strategies (and even categories) are necessary to fully capture the range of approaches to implementation.

Perceived benefits of brief acupuncture for sleep disturbances in postdeployment military service members.

STUDY OBJECTIVES: The purpose of this study was to describe the perceived benefits of manual standardized stress acupuncture (MSSA) for sleep disturbances in service members with deployment exposure. METHODS: This qualitative study was embedded in a 2-arm randomized controlled trial using mixed-methods research that evaluated the effect of weekly MSSA for 4 weeks as an adjunct treatment with abbreviated cognitive-behavioral therapy for insomnia (CBTi) for sleep disturbances in service members. Participants were randomized to either the experimental group (CBTi and MSSA) or the control group (CBTi only). The CBTi consisted of 1 group psychotherapy session for 60 minutes, follow-up telephone therapy for 30 minutes, and an additional four 30-minute follow-up sessions via telephone. Participants provided written journal entries by answering 5 open-ended questions about their treatment experiences at week 5 during the posttreatment assessment. Journal log entries were transcribed verbatim using the Dedoose software. A content analysis method was used to code emerging themes. RESULTS: Three overarching categories were found from the qualitative data: personal challenges in implementing the CBTi sleep strategies, no perception of improvement from treatment, and perceived benefits of treatment. The CBTi/MSSA group reported greater benefits in sleep and in other life areas including mental, physical, and social functioning using content analysis. CONCLUSIONS: Findings of this study showed greater improvements in participants' sleep, mood, physical health, and occupational and social functioning after receiving the combination of CBTi and MSSA. Future research that investigates the long-term effects of CBTi and MSSA may be beneficial among postdeployment service members. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Jane J. Abanes; URL: https://clinicaltrials.gov/ct2/show/NCT04031365; Identifier: NCT04031365. CITATION: Abanes J, Ridner SH, Rhoten B. Perceived benefits of brief acupuncture for sleep disturbances in postdeployment military service members. J Clin Sleep Med. 2021;17(8):1533-1543.

Refinement and Validation of the Head and Neck Lymphedema and Fibrosis Symptom Inventory.

PURPOSE: Lymphedema and fibrosis (LEF) are common yet overlooked late effects of head and neck cancer and its therapy. Lack of reliable and valid measures of head and neck LEF is a critical barrier to the timely identification and management of head and neck LEF. To fill this gap, we developed and pilot tested a 64-item patient-reported outcome measure ( Lymphedema Symptom Intensity and Distress Survey-Head and Neck, LSIDS-H&N). This article aims to report the process of further validation and refinement of the tool. METHODS AND MATERIALS: A prospective, longitudinal study was conducted, and 120 patients with oral cavity and oropharyngeal cancer were recruited. Participants completed the LSIDS-H&N at pretreatment, end of treatment, and every 3 months up to 12 months after treatment. SAS PROC VARCLUS was used to generate preliminary clusters of item responses. Internal consistency of the item responses within each cluster was assessed using Cronbach's alpha. RESULTS: A total of 117 patients completed the study. The participants reported that the LSIDS-H&N was easy to understand and captured their symptoms and medical conditions. However, >50% of participants indicated that the survey was burdensome due to length. Thus, we proceeded with item reduction, and the shortened tool (33-item) was named Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory). The subsequent exploration of symptom clusters identified 7 symptom domain clusters (eg, soft tissue and neurologic toxicity), all of which demonstrated good internal consistency. CONCLUSIONS: The HN-LEF Symptom Inventory has been carefully developed and refined to allow clinicians and researchers to capture LEF-associated symptom burden and function impairments. Additional rigorous psychometric testing of the tool is ongoing to further validate the strength and internal validity of this tool.

The Risk of Subclinical Breast Cancer-Related Lymphedema by the Extent of Axillary Surgery and Regional Node Irradiation: A Randomized Controlled Trial.

PURPOSE: To compare the risk of subclinical breast cancer-related lymphedema (sBCRL) using bioimpedance spectroscopy (BIS) or tape measure (TM) by the extent of axillary surgery and regional nodal irradiation (RNI). METHODS AND MATERIALS: Patients were randomized to surveillance with TM or BIS. A BIS ≥6.5 L-Dex units or TM volume change ≥5 and <10% above presurgical baselines "triggered" sBCRL. The incidence of sBCRL by sentinel node biopsy or axillary lymph node dissection (ALND) with or without RNI was examined for 484 patients. Radiation was categorized as "limited RNI" (axilla level I/II only) or "extensive RNI" (axilla level III or supraclavicular fossa with or without level I/II). RESULTS: At a median follow-up of 20.5 months, 109 of 498 patients (21.9%) triggered sBCRL (BIS 13.5% vs TM 25.6%; P <.001). In patients not receiving RNI, BIS triggered 12.9% of patients undergoing SNB and 25.0% undergoing ALND (P = .18). Extensive RNI significantly increased triggering with BIS versus no RNI after sentinel node biopsy (SNB; 33.3% vs 12.9%; P = .03) but not ALND (30.8% vs 25.0%; P = .69). Triggering by TM was greater than 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery. CONCLUSIONS: The lower triggering rates with BIS and its better discrimination of the risk of sBCRL by receipt and type of RNI compared with TM support its use for posttreatment surveillance to detect sBCRL and to initiate early intervention. The risk of sBCRL increased with more extensive axillary treatment. Patients having ALND or extensive RNI require close surveillance for BCRL. Longer follow-up is required to determine rates of progression to clinical lymphedema.

Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial.

PURPOSE: Lymphedema associated with head and neck cancer (HNC) therapy causes adverse clinical outcomes. Standard treatment includes professionally administered complete decongestive therapy (CDT). Cost and availability of trained therapists are known barriers to therapy. Advanced pneumatic compression devices (APCD) may address these issues. A randomized, wait-list controlled trial was undertaken to evaluate an APCD in post-treatment HNC patients with lymphedema. MATERIAL AND METHODS: Eligible patients had completed treatment for HNC, were disease free, and had lymphedema at enrollment. Participants were randomized to wait-list lymphedema self-management (standard of care) or lymphedema self-management plus the use of the APCD bid. Safety (CTCAE V4.0) and feasibility were primary endpoints; secondary endpoints included efficacy measure by objective examination and patient reported outcomes (symptoms, quality of life, function), adherence barriers, and satisfaction. Assessments were conducted at baseline and weeks 4 and 8. RESULTS: Forty-nine patients were enrolled (wait-list n = 25; intervention n = 24). In total, forty-three patients completed the study. No device-related Serious Adverse Events were reported. Most patients used the APCD once per day, instead of the prescribed twice per day, citing time related factors as barriers to use. APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001, right view p = 0.004, left p = 0.005), as well as less reported pain. CONCLUSION: This trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in head and neck cancer patients. In addition, preliminary data supports efficacy.

A qualitative examination of patient priorities and preferences during treatment decision-making for recurrent head and neck cancer.

PURPOSE: Patients with recurrent head and neck cancer (HNC) may feel overwhelmed at the prospect of having to consider treatment options particularly if they recently completed treatment for their primary disease or when they have no options that may lead to long-term survival. The purpose of this study was to examine patient priorities and preferences during treatment decision-making for recurrent HNC. METHODS: Individuals with newly diagnosed recurrent HNC were recruited at a National Cancer Institute-Designated Cancer Center. Participants were interviewed using a structured interview guide. Descriptive statistics were used to describe participants, and qualitative template analysis was used to analyze interview data. RESULTS: Participants (n = 38) considered information from healthcare providers, likelihood of treatment success, and other patient-specific factors in making their treatment decisions. CONCLUSIONS: Although patients with recurrent HNC endorse a myriad of decision-making factors, the recommendation of their healthcare provider and the likelihood of treatment success are of paramount importance. Future research should focus on methods to rapidly identify patient priorities at the time of diagnosed recurrence while respecting patient coping and communication styles.

Health-Care Professionals Perceived Barriers to Effective Cancer Pain Management in the Home Hospice Setting: Is Dying at Home Really Best?

Hospice health-care professionals (HCP) evaluate and manage cancer pain in patient homes. This study explores HCP's perceptions of barriers that affect pain management for home hospice cancer patients. A convenience sample of 20 experienced hospice HCP were recruited from a regional hospice agency. Data were collected through two focus groups using semistructured interviews and analyzed using a constant comparative approach to generate themes. An unexpected finding revealed patient's religious and cultural beliefs about suffering and family caregiver's beliefs that patients deserve to suffer due to past actions are barriers to pain management in home hospice. Hospice HCP can identify patients at risk for suffering at the end of life. Interventions targeting spiritual suffering and needs are needed. Home hospice HCP have an ethical obligation to address undue suffering through family's withholding of necessary pain medications and should consider alternative placement when home is not suitable for a peaceful death.