Development of a core set of outcome measures to be applied toward breast cancer-related lymphedema core outcome domains.

PURPOSE: For breast cancer survivors (BCS) living with breast cancer-related lymphedema (BCRL), what outcome measures (OMs) are recommended to be used to measure standardized outcome domains to fully assess the burden of the disease and efficacy of interventions? An integral component of a standardized core outcome set (COS) are the OMs used to measure the COS. METHODS: A supplemental online survey was linked to a Delphi study investigating a COS for BCRL. OMs were limited to a maximum of 10 options for each outcome domain (OD). There were 14 ODs corresponding to the International Classification of Functioning, Disability, and Health (ICF) framework and respondents rated the OMs with a Likert level of recommendation. The feasibility of the listed OMs was also investigated for most outpatient, inpatient, and research settings. RESULTS: This study identified 27 standardized OMs with a few ODs having 2-3 highly recommended OMs for proper measurement. A few of the recommended OMs have limitations with reliability due to being semi-quantitative measures requiring the interpretation of the rater. CONCLUSION: Narrowing the choices of OMs to 27 highly recommended by BCRL experts may reduce selective reporting, inconsistency in clinical use, and variability of reporting across interdisciplinary healthcare fields which manage or research BCRL. There is a need for valid, reliable, and feasible OMs that measure tissue consistency. Measures of upper extremity activity and motor control need further research in the BCS with BCRL population.

Symptoms and symptom clusters in patients with hepatocellular carcinoma and commonly used instruments: An integrated review.

Objective: This study aimed to synthesize the available knowledge of identifying hepatocellular carcinoma (HCC) symptoms and symptom clusters in patients with HCC and instruments used for these assessments to maximize symptom management. Methods: Whittemore and Knafl's integrative review method was employed to guide a systematic search for literature in five databases (PubMed, ScienceDirect, Scopus, CINAHL, and ThaiJO). The retrieved articles were limited to those which were peer-reviewed, published between 2005 and 2022, and had English abstracts. All of identified studies were screened, extracted, and analyzed independently by two researchers. Result: Fourteen articles were included in this review. They were grouped into three themes: symptoms, symptom assessment, and symptom clusters of HCC patients. Fatigue, lack of energy, stomach or abdominal pain/distension, loss of appetite, change in taste, sleep disturbance, distress, and sadness are the most prevalent symptoms reported in HCC patients. The different concurrent symptoms are related to the stage and treatment. Five types of symptom assessment instruments were commonly used (symptoms-specific HCC, general cancer symptom, measuring non-symptom constructs, measuring specific symptoms, such as fatigue, sleep disturbance, anxiety, and depression, and symptom assessment with clinical examination). Furthermore, the symptom clusters in HCC patients were classified into five categories: 1) pain-related symptoms, 2) gastrointestinal symptoms, 3) neuropsychological symptom clusters and sensory symptoms, 4) liver dysfunction-related symptom clusters, and 5) others (including sickness symptom clusters, fatigue clusters, location pain symptoms, and asymptomatic or symptomatic). Conclusion: The findings of this review add to the body of knowledge on symptoms, symptom assessment, and symptom clusters in patients with HCC. Despite a variety of instruments being available, none covers all symptoms experienced by HCC patients. It is recommended that future studies should include larger and more homogenous samples to evaluate assessment instruments more precisely, avoid ambiguity in classifying symptoms into symptom clusters, and increase the effectiveness of symptom management.

Development of a core outcome set for breast cancer-related lymphedema: a Delphi study.

PURPOSE: For breast cancer survivors (BCS) living with breast cancer-related lymphedema (BCRL), what outcome domains (OD) should be measured to assess the burden of the disease and efficacy of interventions? A Core Outcome Set (COS) that promotes standardized measurement of outcomes within the constraints of time influenced by work environments is essential for patients and the multidisciplinary professionals that manage and research BCRL. METHODS: Using Delphi methodology, a multidisciplinary group of BCRL experts (physical and occupational therapists, physicians, researchers, physical therapist assistants, nurses, and massage therapist) completed two waves of online surveys. BCRL expert respondents that completed the first survey (n = 78) had an average of 26.5 years in practice, whereas, respondents who completed the second survey (n = 33) had an average of 24.9 years. ODs were included in the COS when consensus thresholds, ranging from 70% to 80%, were met. RESULTS: A total of 12 ODs made up the COS. Reaching a minimum consensus of 70%; volume, tissue consistency, pain, patient-reported upper quadrant function, patient-reported health-related quality of life, and upper extremity activity and motor control were recommended at different phases of the BCRL continuum in a time-constrained environment. Joint function, flexibility, strength, sensation, mobility and balance, and fatigue met an 80% consensus to be added when time and resources were not constrained. CONCLUSION: The COS developed in this study thoroughly captures the burden of BCRL. Using this COS may reduce selective reporting, inconsistency in clinical use, and variability of reporting across interdisciplinary healthcare fields, which manage or research BCRL.

Lymphedema self-care: economic cost savings and opportunities to improve adherence.

BACKGROUND: Breast cancer-related lymphedema (BCRL) imposes a significant economic burden on patients, providers, and society. There is no curative therapy for BCRL, but management through self-care can reduce symptoms and lower the risk of adverse events. MAIN BODY: The economic burden of BCRL stems from related adverse events, reductions in productivity and employment, and the burden placed on non-medical caregivers. Self-care regimens often include manual lymphatic drainage, compression garments, and meticulous skin care, and may incorporate pneumatic compression devices. These regimens can be effective in managing BCRL, but patients cite inconvenience and interference with daily activities as potential barriers to self-care adherence. As a result, adherence is generally poor and often worsens with time. Because self-care is on-going, poor adherence reduces the effectiveness of regimens and leads to costly treatment of BCRL complications. CONCLUSION: Novel self-care solutions that are more convenient and that interfere less with daily activities could increase self-care adherence and ultimately reduce complication-related costs of BCRL.

COVID-Specific Long-term Sequelae in Comparison to Common Viral Respiratory Infections: An Analysis of 17 487 Infected Adult Patients.

Background: A better understanding of long-term health effects after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become one of the health care priorities in the current pandemic. We analyzed a large and diverse patient cohort to study health effects related to SARS-CoV-2 infection occurring >1 month postinfection. Methods: We analyzed 17 487 patients who received diagnoses for SARS-CoV-2 infection in a total of 122 health care facilities in the United States before April 14, 2022. Patients were propensity score-matched with patients diagnosed with the common cold, influenza, or viral pneumonia from March 1, 2020, to April 1, 2021. For each outcome, SARS-CoV-2 was compared with a generic viral respiratory infection (VRI) by predicting diagnoses in the period between 30 and 365 days postinfection. Both coronavirus disease 2019 (COVID-19) and VRI patients were propensity score-matched with patients with no record of COVID-19 or VRI, and the same methodology was applied. Diagnoses where COVID-19 infection was a significant positive predictor in both COVID-19 vs VRI and COVID-19 vs control comparisons were considered COVID-19-specific effects. Results: Compared with common VRIs, SARS-CoV-2 was associated with diagnoses of palpitations, hair loss, fatigue, chest pain, dyspnea, joint pain, and obesity in the postinfectious period. Conclusions: We identify that some diagnoses commonly described as "long COVID" do not appear significantly more frequent post-COVID-19 infection compared with other common VRIs. We also identify sequelae that are specifically associated with a prior SARS-CoV-2 infection.

Lymphoedema, a significant health problem in Israel: A descriptive community-based study.

Lymphoedema (LE) is recognised as a chronic disabling disease. Knowledge on patient characteristics, treatments, and outcomes in Israel is lacking. The aim of the study was to (a) describe demographic and health characteristics, treatments, utilisation, and functional outcomes of patients receiving physical therapy due to LE in a large nationwide healthcare provider in Israel; and (b) assess the feasibility of conducting a future practice-based evidence (PBE) study. This is a retrospective observational cohort study. Descriptive analyses of an electronic medical record database were performed. Data from 6013 patient episodes were analysed. A high proportion of patients had two or more comorbidities (80%) and chronic medication use (85%) with increasing rates over the 8-year period. The most frequent LE classification was stage 2 (45%). A majority of LE was in the lower limbs (51%) with increasing rates over the years. The most frequent treatment-related activity was measuring limb circumference and the most frequent intervention was educating for self-management. This study provides a first comprehensive description of patient characteristics receiving physical therapy for LE in Israel. The available database offers an opportunity for PBE studies. Recommendations for improvements in specific data collection processes were identified.

A systematic review of m-health apps on managing side effects of breast cancer treatment.

PURPOSE: After breast cancer treatment, women with breast cancer may experience distress caused by treatment side effects, both in physical and psychological aspects. Technology use is increasing in favor among women. Therefore, it is essential to update the scientific evidence regarding mobile and web apps' effectiveness in managing the side effects of breast cancer treatments for breast cancer survivors. The purpose of this systematic review was to investigate the scientific evidence on the effectiveness of mobile and web apps in managing the side effects of breast cancer treatments among this group. METHODS: A literature search was conducted using ScienceDirect, Scopus, PubMed, CINAHL, and Cochrane. Published papers in English focused on mobile and web apps and the side effects of breast cancer treatment in breast cancer survivors were selected. The search reviewed studies from January 2011 to December 2021. From a total of 925 retrieved manuscripts, 11 studies were included for analysis. RESULTS: The findings showed that mobile apps were more frequently used and more likely to be an effective method for managing the side effects of breast cancer treatment among breast cancer survivors. The content in web or mobile apps for breast cancer survivors should include five categories: (1) information about cancer, (2) overview of cancer care, (3) opportunities for interaction with other people, (4) symptom management strategies, and (5) feedback about cancer treatment side effect management. However, a few studies examined the effects of a combination of mobile and web apps in managing breast cancer treatment side effects. Therefore, future research is needed to examine solo and combination use. In addition, more rigorous studies are warranted to examine these interventions. CONCLUSIONS: Nurses may refer survivors to these resources to obtain more information and effectively manage the signs and symptoms of breast cancer and its treatment side effects.

A Multiple Case Study of Latina Breast Cancer Survivors Returning to Work With Breast Cancer-Related Lymphedema: Adaptation, Resilience, and Quality of Life.

Introduction: Breast cancer-related lymphedema (BCRL), a side effect of cancer treatment, may negatively impact the ability to perform work. Factors such as delayed diagnosis, late-stage disease, and a high percentage of service occupations may challenge work choices for Latinas after BCRL diagnosis. Methods: Our multiple case study explored work experiences and quality of life (QOL) for Hispanic/Latina survivors. Participants completed demographic and short form-36 (SF-36) surveys. Semi-structured interviews focused on how work environment, self-management, and QOL were influenced by BCRL. Thematic analysis of cases used In Vivo and descriptive coding and constant cross-case comparative methods. Results: Analysis illustrated how Hispanic/Latina survivors perceive the influence of BCRL on work experience as requiring adaptation and personal resilience. Participants identified BCRL knowledge gap challenges and described coping with physical, psychosocial, and work activity changes. They described creative work adaptations and discussed BCRL's impact on both positive and negative interpersonal perceptions. Strong support from family, friends, and colleagues contributed to improved QOL and continued work activities. Conclusion: Future research should incorporate coping strategies and creative management of BCRL to optimize work activities across the lifespan. These strategies can provide guidance for the creation of survivorship care plans, education of healthcare professionals (HCPs), and lifelong occupational support.

Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE).

OBJECTIVE: Advanced pneumatic compression devices (APCDs) have been shown to be an effective intervention for lymphedema when used as part of a self-care maintenance treatment regimen. However, adherence to self-care has been poor, and APCDs require patients to be immobile during treatment. We evaluated the safety and efficacy of a novel nonpneumatic compression device (NPCD) for treating lymphedema vs an APCD. METHODS: A randomized, crossover head-to-head investigation was performed at five U.S. sites in 2021. The patients had been randomized to either the NPCD or a commercially available APCD. The patients used the randomly assigned initial device for 28 days with a 4-week washout period before a comparable 28-day use of the second device. RESULTS: Data from 50 adult women with unilateral breast cancer-related lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean reduction in the limb edema volume (64.6% vs 27.7%; P < .001), significantly greater mean improvements in quality of life scores, greater adherence (95.6% vs 49.8%; P < .001), and greater satisfaction with the device (90% vs 14%; P < .001). The patients indicated that use of the NPCD facilitated exercise and was convenient for travel. No adverse events were reported. CONCLUSIONS: The results have shown that the novel NPCD is an effective maintenance treatment for reducing the limb volume in patients with breast cancer-related lymphedema. The NPCD device was more effective than an APCD and resulted in greater adherence to self-care interventions and greater patient satisfaction.

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study.

A diagnosis of lymphedema comes with a lifetime requirement for careful self-care and treatment to control skin deterioration and the consequences of excessive fluid and protein buildup leading to abnormal limb volume and an increased risk of infection. The burden of care and psychosocial aspects of physical disfiguration and loss of function are associated with compromised quality of life (QoL). The current standard therapeutic intervention is complex decongestive therapy with manual lymph drainage and frequent wearing of compression garments. With insurance limitations on therapy visits and the time and travel required, additional home treatment options are needed. Pneumatic compression pumps that mimic the manual massage pressure and pattern are sometimes prescribed, but these are bulky, difficult to apply, and require immobility during treatment. An open-label pilot study in 40 subjects was performed to evaluate the QoL and limb volume maintenance efficacy of a novel wearable compression system (Dayspring™) that is low profile, easy to use, and allows for mobility during treatment. After 28 days of use, subjects had a statistically significant 18% (p < 0.001) improvement in overall QoL as measured by the Lymphedema Quality-of-Life Questionnaire compared with baseline. Individual QoL domains, and limb volume improved with therapy. Adherence was 98% over the course of the study. Results of the clinical evaluation suggest the Dayspring wearable compression device is safe and effective and improves QoL and limb volume. The novel, low-profile device is easy to use and allows for mobility during treatment, addressing a potential barrier to adherence with pneumatic compression devices.

Lymphedema rehabilitation: Provision and practice patterns among service providers: National survey.

Information on the current practices and quantification of lymphedema service may be beneficial to promote and improve the current health care system. Therefore, this study aimed to describe the characteristics of lymphedema practitioners, and lymphedema patients' profiles, and provide a comprehensive picture of lymphedema service provision in Saudi Arabia. A cross-sectional study design used an online survey to gather data. The survey included information about demographic and professional characteristics of lymphedema practitioners, lymphedema profiles, questions on the services provided, and perceived barriers in providing services. Eighteen lymphedema practitioners (38%) responded to the survey. Most of the respondents were physical therapists (94%), who had completed 135 hours of basic training course, and were certified as lymphedema therapists (89%). Most of these practitioners were in Riyadh (58%), Jeddah (25%), and Dammam (17%). About 75% of patients seen by practitioners had secondary lymphedema, predominately breast cancer-related lymphedema (47%). The average number of lymphedema practitioners per service is three. The perceived barriers reported included an inadequate number of certified therapists (100%), difficulties with transportation and lack of financial support (each; 72%), and limited space for lymphedema practice/management (89%). The results suggest lymphedema practitioners provide reasonable services for lymphedema patients; however, services are still limited and needs are unmet. Therefore, more staffing is required to promote awareness of the condition and related services, to develop and implement appropriate educational strategies, and improve geographical and multidisciplinary coordination of the services in Saudi Arabia.

The impact of breast cancer-related lymphedema on rural and small-town Survivors' return-to-work and quality of life: A multiple-case study.

BACKGROUND: Breast cancer-related lymphedema (BCRL) is a lifelong condition. Millions who develop breast cancer are younger than retirement age and at a lifetime risk for developing BCRL. Rural and small-town survivors may face unique challenges in terms of access to health care and BCRL/survivorship resources. This multiple-case study describes how BCRL influences the work experiences and quality of life (QoL) of survivors living in rural and small towns in Missouri. METHODS AND MATERIALS: Thirteen survivors from rural and small towns in Missouri completed semi-structured interviews and a standardized QoL instrument. Cases were analyzed using in-vivo and open-coding techniques and constant cross-case comparative methods. Twelve of the 13 participants' data are synthesized into themes to represent an illustrative case. The 13th case is presented as a contradictory (rival) case. RESULTS: Four themes are represented within the illustrative case - multiple medical encounters; the development of self-care routines; the reciprocity of work/live activities, triggers, and adjustments; and rural/small-town cultural impact. Upon BCRL diagnosis, survivors received intensive treatments, eventually establishing self-care routines. Survivors identified strategies for working around their BCRL when completing work and home responsibilities. The contradictory (rival) case was more recently diagnosed and, as such, had not established self-care and coping mechanisms in the same way. CONCLUSIONS AND IMPLICATIONS: Survivors alleviate BCRL symptoms and improve their QoL by establishing self-care strategies. This provides guidance for client-centered survivorship care-planning and occupational rehabilitation of rural survivors with BCRL. This study provides the foundation for developing information for rural survivors that supports mental preparation and coping skills for BCRL self-management.

Manual Lymphedema Drainage for Reducing Risk for and Managing Breast Cancer-Related Lymphedema After Breast Surgery: A Systematic Review.

OBJECTIVE: To examine the effects of manual lymphatic drainage (MLD) on reducing the risk of and managing breast cancer-related lymphedema (BCRL). DATA SOURCES: The electronic databases ScienceDirect, Scopus, PubMed, and CINAHL were searched for articles published in the English language from January 2000 to June 2020. STUDY SELECTION: A total of 518 articles were retrieved. After the removal of duplicates, 472 articles remained, 433 of which were excluded based on title and abstract consideration. Thereafter, 39 studies were further inspected, and 27 articles were excluded because they were not randomized controlled trials, did not measure BCRL, and/or were an incomplete study. Ten studies were included for the final review. DATA EXTRACTION: Data from the 10 studies were extracted and compiled into a summary table. DATA SYNTHESIS: Based on the results of this systematic review, it cannot be concluded that MLD helps reduce the risk of BCRL for women after breast surgery. Regarding the effect of MLD on managing BCRL, the findings indicate that MLD alone or MLD combined with other treatments was likely to give similar benefits in terms of reducing arm volume for women diagnosed with BCRL. CONCLUSION: Scientific evidence to support the benefits of MLD on preventing or reducing BCRL remains unclear. More rigorous studies to confirm findings on the effectiveness of MLD are needed.

Associations between religious and spiritual variables and neuroimmune activity in survivors of breast cancer: a feasibility study.

PURPOSE: Chronic stress is associated with neuroimmune inflammation and adverse outcomes in breast cancer survivors. Some breast cancer survivors rely on religious and spiritual (R/S) variables to manage stress after breast cancer treatment. A spiritually based psychoneuroimmunological (PNI) model of health suggests that R/S variables influence neuroimmune activity; however, these associations are not well-established. A pilot study was conducted to assess the feasibility of studying associations between R/S variables and neuroimmune biomarkers in breast cancer survivors. METHOD: Salivary alpha-amylase (sAA) and interleukin-6 (IL-6) were sampled among women previously treated for breast cancer. The primary aim was to assess feasibility and acceptability of the sampling protocol. A secondary aim explored associations between sAA, IL-6, R/S variables, and health outcomes. RESULT: Forty-one women completed the study. Biomarker sampling yielded 246 acceptable specimens used for analysis. SAA was detectable in 96% of specimens and IL-6 was detectable in 44% of specimens. The R/S variables with the strongest associations to sAA were spiritual self-rank (rs = .39; p < .05) and forgiveness (rs = .40; p < .05). The R/S variable with the strongest association to salivary IL-6 was positive congregational support (rs = .42; p < .05). CONCLUSION: Feasibility and acceptability of the sampling protocol were confirmed. Reference ranges for sAA and IL-6 for female breast cancer survivors are presented. Results suggest that spiritual beliefs and religious practices are associated with neuroimmune activity, adding credence to a spiritually based PNI model of health. Findings lay the foundations for future R/S-based interventions to promote health and well-being in breast cancer survivors.

Factors Impacting Management of Breast Cancer-Related Lymphedema (BCRL) in Hispanic/Latina Breast Cancer Survivors: A Literature Review.

INTRODUCTION: Breast cancer-related lymphedema (BCRL) is a treatment sequela with negative physical and psychological implications. BCRL is a lifetime concern for survivors and is currently incurable. With the increase in the Latino population in the United States, it is critical for the cancer care community to address factors that increase BCRL risk and negatively impact long-term quality of life. This literature review undertook to identify successful intervention strategies for BCRL among Latina survivors. METHODS: Multiple databases were searched for published articles from 2006 to 2020. PRISMA guidelines were utilized. Data were extracted related to physical activity, diet, and psychosocial stress concerns of Latinas at risk for or living with BCRL. RESULTS: Eleven interventions combined education and skill-building techniques to address physical activity, diet, and stress management for BCRL. Family involvement, peer-mentoring, culturally tailored education, and self-care skill development were identified as important for Latina survivors. CONCLUSION: Latina survivors may benefit from culturally tailored BCRL education programs and self-management interventions. Health care professionals and researchers should consider cultural influences when developing clinical intervention strategies to enhance outcomes for Latinas at risk for living with BCRL. In addition, including family members and/or peers in such strategies may be helpful to Latina survivors.

Uncovering Family Treatment Decision-Making Processes: The Value and Application of Case Study Methods to Family Research.

Research on how and why family processes influence phenomena is essential to advancing many areas of science. Case study methods offer an approach that overcomes some of the sampling and analysis obstacles researchers face when studying families. This article aims to illustrate the benefits of case study methods for studying complex family processes using an example from treatment decision-making in sickle cell disease. Using survey, observation, and interview data from various family members within multiple family units, we detail our application of the following analytic strategies: (a) proposition-building, (b) pattern-matching, and (c) cross-case synthesis. Incorporating propositions from a conceptual framework assisted us in study development, data collection, and analysis. Development of graphs and matrices to create thematic family profiles uncovered how and why treatment decision-making occurred as a family process in a pediatric chronic illness. Case study methods are an established, but innovative approach to investigating various phenomena in families.

Breast cancer-related lymphedema and quality of life: A qualitative analysis over years of survivorship.

OBJECTIVES: The study purpose was to examine perspectives of women with newly diagnosed breast cancer-related lymphedema (BCRL) regarding their quality of life over seven years. METHOD: Data were collected over seven years using the Lymphedema and Breast Cancer Questionnaire (LBCQ). Participants with BCRL answered open-ended questions corresponding to changes in mood and lifestyle from post-op through annual interviews and surveys. Self-reported data from 97 participants with BCRL were analyzed using in vivo coding and template-style content analysis to elicit the impact of BCRL on quality of life domains. RESULTS: Data saturation was achieved as participants neared 30 to 36 months post- breast cancer diagnosis. Three major themes were identified related to BCRL's impact on: physical function; daily living and social function; and psychological function. DISCUSSION: Findings suggest that BCRL impacts quality of life not only soon after diagnosis, but also throughout survivorship years. Healthcare providers should develop programs to enhance quality of life for survivors with BCRL.

Rural-Urban Differences in Neuroimmune Biomarkers and Health Status Among Women Living With Breast Cancer.

BACKGROUND: Because of chronic emotional and psychosocial stressors following breast cancer (BC) treatment, BC survivors are at risk of neuroimmune dysfunction in survivorship. Rural BC survivors experience more health disparities than urban BC survivors. Rural-urban residence as a variable on neuroimmune activity in extended BC survivorship continuum has not been explored. OBJECTIVE: To report the feasibility of studying relationships between neuroimmune activity and perceived health in rural and urban BC survivors. METHODS: Data from a pilot study of BC survivors (n = 41) were analyzed. Participants were rural (n = 16) and urban (n = 25). Participants completed Medical Outcomes Study Short-Form Version 2 Health Survey questionnaires and provided salivary specimens for analysis of salivary α-amylase (sAA), cortisol, and interleukin 6 (IL-6). Rural-Urban Commuting Area Codes were used to determine rural or urban residence. RESULTS: Differences in immune activity were observed between rural and urban BC survivors (U = 34, P < .05). No rural-urban group differences in neuroendocrine activity were observed. Relationships were observed between perceptions of mental health and sAA (P < .05) in rural BC survivors and between perceptions of mental health and IL-6 (P < .05) in urban BC survivors. Interleukin 6 was positively associated with perceptions of physical health (P < .05) in rural BC survivors. CONCLUSION: Pilot data suggest rural-urban residence may be a factor in relationships between neuroimmune function (ie, sAA and IL-6) and perceived health status, particularly social functioning in women with BC. Additional studies with powered designs are indicated. IMPLICATIONS FOR PRACTICE: Although evidence is limited, data support the feasibility of studying relationships between sAA and IL-6 and perceptions of health in women with BC.

GOG 244 - The Lymphedema and Gynecologic cancer (LeG) study: The impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function.

OBJECTIVE: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244. METHODS: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%. RESULTS: In 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p < 0.001), body image (p < 0.001), sexual and vaginal function (p < 0.001), limb function (p < 0.001), and cancer distress (p < 0.001). There were no significant differences in sexual activity rates between those with and without LLE symptoms. CONCLUSIONS: LLE is significantly detrimental to QOL, daily function, and body image. Clinical intervention trials to prevent and manage this chronic condition after gynecologic cancer surgery are needed.