GOG 244-The lymphedema and gynecologic cancer (LEG) study: Incidence and risk factors in newly diagnosed patients.

OBJECTIVES: To evaluate the incidence and risk factors for lymphedema associated with surgery for gynecologic malignancies on GOG study 244. METHODS: Women undergoing a lymph node dissection for endometrial, cervical, or vulvar cancer were eligible for enrollment. Leg volume was calculated from measurements at 10-cm intervals starting 10 cm above the bottom of the heel to the inguinal crease. Measurements were obtained preoperatively and postoperatively at 4-6 weeks, and at 3-, 6-, 9-, 12-, 18-, and 24- months. Lymphedema was defined as a limb volume change (LVC) ≥10% from baseline and categorized as mild: 10-19% LVC; moderate: 20-40% LVC; or severe: >40% LVC. Risk factors associated with lymphedema were also analyzed. RESULTS: Of 1054 women enrolled on study, 140 were inevaluable due to inadequate measurements or eligibility criteria. This left 734 endometrial, 138 cervical, and 42 vulvar patients evaluable for LVC assessment. Median age was 61 years (range, 28-91) in the endometrial, 44 years (range, 25-83) in the cervical, and 58 years (range, 35-88) in the vulvar group. The incidence of LVC ≥10% was 34% (n = 247), 35% (n = 48), and 43% (n = 18), respectively. The peak incidence of lymphedema was at the 4-6 week assessment. Logistic regression analysis showed a decreased risk with advanced age (p = 0.0467). An exploratory analysis in the endometrial cohort showed an increased risk with a node count >8 (p = 0.033). CONCLUSIONS: For a gynecologic cancer, LVC decreased with age greater than 65, but increased with a lymph node count greater than 8 in the endometrial cohort. There was no association with radiation or other risk factors.

GOG 244 - The LymphEdema and Gynecologic cancer (LEG) study: The association between the gynecologic cancer lymphedema questionnaire (GCLQ) and lymphedema of the lower extremity (LLE).

OBJECTIVE: To explore whether patient-reported lymphedema-related symptoms, as measured by the Gynecologic Cancer Lymphedema Questionnaire (GCLQ), are associated with a patient-reported diagnosis of lymphedema of the lower extremity (LLE) and limb volume change (LVC) in patients who have undergone radical surgery, including lymphadenectomy, for endometrial, cervical, or vulvar cancer on Gynecologic Oncology Group (GOG) study 244. METHODS: Patients completed the baseline and at least one post-surgery GCLQ and LVC assessment. The 20-item GCLQ measures seven symptom clusters-aching, heaviness, infection-related, numbness, physical functioning, general swelling, and limb swelling. LLE was defined as a patient self-reported LLE diagnosis on the GCLQ. LVC was measured by volume calculations based on circumferential measurements. A linear mixed model was fitted for change in symptom cluster scores and GCLQ total score and adjusted for disease sites and assessment time. RESULTS: Of 987 eligible patients, 894 were evaluable (endometrial, 719; cervical, 136; vulvar, 39). Of these, 14% reported an LLE diagnosis (endometrial, 11%; cervical, 18%; vulvar, 38%). Significantly more patients diagnosed versus not diagnosed with LLE reported ≥4-point increase from baseline on the GCLQ total score (p < 0.001). Changes from baseline were significantly larger on all GCLQ symptom cluster scores in patients with LLE compared to those without LLE. An LVC increment of >10% was significantly associated with reported general swelling (p < 0.001), heaviness (p = 0.005), infection-related symptoms (p = 0.002), and physical function (p = 0.006). CONCLUSIONS: Patient-reported symptoms, as measured by the GCLQ, discerned those with and without a patient-reported LLE diagnosis and demonstrated predictive value. The GCLQ combined with LVC may enhance our ability to identify LLE.

Religiousness, Spirituality, and Salivary Cortisol in Breast Cancer Survivorship: A Pilot Study.

BACKGROUND: Psychoneuroimmunological theory suggests a physiological relationship exists between stress, psychosocial-behavioral factors, and neuroendocrine-immune outcomes; however, evidence has been limited. OBJECTIVE: The primary aim of this pilot study was to determine feasibility and acceptability of a salivary cortisol self-collection protocol with a mail-back option for breast cancer survivors. A secondary aim was to examine relationships between religiousness/spirituality (R/S), perceptions of health, and diurnal salivary cortisol (DSC) as a proxy measure for neuroendocrine activity. METHODS: This was an observational, cross-sectional study. Participants completed measures of R/S, perceptions of health, demographics, and DSC. RESULTS: The sample was composed of female breast cancer survivors (n = 41). Self-collection of DSC using a mail-back option was feasible; validity of mailed salivary cortisol biospecimens was established. Positive spiritual beliefs were the only R/S variable associated with the peak cortisol awakening response (rs = 0.34, P = .03). Poorer physical health was inversely associated with positive spiritual experiences and private religious practices. Poorer mental health was inversely associated with spiritual coping and negative spiritual experiences. CONCLUSIONS: Feasibility, validity, and acceptability of self-collected SDC biospecimens with an optional mail-back protocol (at moderate temperatures) were demonstrated. Positive spiritual beliefs were associated with neuroendocrine-mediated peak cortisol awakening response activity; however, additional research is recommended. IMPLICATIONS FOR PRACTICE: Objective measures of DSC sampling that include enough collection time points to assess DSC parameters would increase the rigor of future DSC measurement. Breast cancer survivors may benefit from nursing care that includes spiritual assessment and therapeutic conversations that support positive spiritual beliefs.

Patient Perceptions of Barriers to Self-Management of Breast Cancer-Related Lymphedema.

Breast cancer survivors are at lifetime risk for the development of breast cancer-related lymphedema, a chronic, potentially debilitating condition that requires life-long symptom management. Suboptimal self-management rates suggest that health care providers may not be offering educative-support options that are customized to patient-perceived needs. An Institutional Review Board-approved focus group ( N = 9) and mailed surveys ( N = 15) were used to identify (a) barriers to lymphedema self-management, (b) how breast cancer survivors with lymphedema defined education and support, (c) what type of education and support they had received, and (d) what kind of education and support they wanted. Physiological, psychological, and psychosocial factors were identified as barriers to successful lymphedema self-management. One of the main barriers identified was lack of education about lymphedema treatment and risk reduction. In addition, more than half defined support as "prescriptions" and "referrals"; therefore, it is unclear whether patients were exposed to support other than medical treatment.

Skin and Wound Care in Lymphedema Patients: A Taxonomy, Primer, and Literature Review.

BACKGROUND: Lymphedema is a condition of localized protein-rich swelling from damaged or malfunctioning lymphatics. Because the immune system is compromised, there is a high risk of infection. Infection in patients with lymphedema may present in a variety of ways. OBJECTIVE: The goals of this review were to standardize the terminology of skin breakdown in the context of lymphedema, synthesize the available information to create best practice recommendations in support of the American Lymphedema Framework Project update to its Best Practices document, and create recommendations for further research. DATA SOURCES: Publications on skin care and wounds were retrieved, summarized, and evaluated by a team of investigators and clinical experts. STUDY SELECTION AND DATA EXTRACTION: Terms for lymphedema-associated skin breakdown were compiled and paired with photographs of commonly noted skin changes among patients with lymphedema. A list of standard dermatological terms was created. A more extensive literature search was then conducted by all authors. DATA SYNTHESIS: Skin disorders associated with lymphedema have been classified into 5 categories. Descriptions, photographs, and recommendations for treatment are presented. CONCLUSIONS: Skin care is an important defense against infection. Because of the lack of research, a consensus of thought and content leaders' opinion should guide the best practices for wound care in lymphedema.

The long-term risk of upper-extremity lymphedema is two-fold higher in breast cancer patients than in melanoma patients.

BACKGROUND AND OBJECTIVES: We assessed the cumulative incidence, symptoms, and risk factors for upper-extremity lymphedema in breast cancer and melanoma patients undergoing sentinel lymph node biopsy or axillary lymph node dissection. METHODS: Patients were recruited preoperatively (time 0) and assessed at 6, 12, and 18 months postoperatively. Limb volume change (LVC) was measured by perometry. Lymphedema was categorized as none, mild (LVC 5-9.9%), or moderate/severe (LVC≥10%). Symptoms were assessed with a validated lymphedema instrument. Longitudinal logistic regression analyses were conducted to identify risk factors associated with moderate/severe lymphedema. RESULTS: Among 205 breast cancer and 144 melanoma patients, the cumulative incidence of moderate/severe lymphedema at 18 months was 36.5% and 35.0%, respectively. However, in adjusted analyses, factors associated with moderate/severe lymphedema were breast cancer (OR 2.0, P = 0.03), body mass index ≥ 30 kg/m(2) (OR 1.6, P = 0.04), greater number of lymph nodes removed (OR 1.05, P < 0.01), and longer interval since surgery (OR 2.33 at 18 months, P < 0.01). CONCLUSIONS: Lymphedema incidence increased over time in both cohorts. However, the adjusted risk of moderate/severe lymphedema was two-fold higher in breast cancer patients. These results may be attributed to surgical treatment of the primary tumor in the breast and more frequent use of radiation.

Breast Cancer Survivorship Care: Targeting a Colorectal Cancer Education Intervention.

Breast cancer survivors are at risk of developing a second primary cancer. Colorectal cancer (CRC) is one of the leading second primary cancers, and it is often preventable. We developed a multi-component educational tool to inform and encourage women breast cancer survivors to engage in CRC screening. To assess the strengths and weakness of the tool and to improve the relevancy to the target audience, we convened four focus groups of women breast cancer survivors in Missouri. We also assessed the potential impact of the tool on the knowledge, attitudes, and beliefs regarding CRC and collected information on the barriers to CRC screening through pre- and post-focus groups' questionnaires. A total of 43 women breast cancer survivors participated and provided very valuable suggestions on design and content to update the tool. Through the process and comparing pre- and post-focus group assessments, a significantly higher proportion of breast cancer survivors strongly agreed or agreed that CRC is preventable (78.6% vs. 96.9%, p = 0.02) and became aware that they were at a slightly increased risk for CRC (18.6% vs. 51.7%, p = 0.003). The most cited barrier was the complexity of preparation for colonoscopy.

Perspectives of the Breast Cancer Survivorship Continuum: Diagnosis through 30 Months Post-Treatment.

This study explored breast cancer survivors' perspectives regarding their experiences of the survivorship continuum from diagnosis through 30 months post-treatment. The sample included women (N = 379) with newly-diagnosed breast cancer undergoing treatment at a Midwestern university-affiliated cancer center. Semi-structured interviews were conducted using the Lymphedema and Breast Cancer Questionnaire at time of diagnosis, post-operatively, quarterly during the first year, and then semi-annually thereafter through 30 months post-treatment. A mixed-methodology was used to analyze participants' comments. Themes central to long-term survivorship experiences included social support, positive worldviews, breast cancer and lymphedema health literacy, religious/spiritual beliefs, self-empowerment, and recovery expectations. These themes were consistent with a psychoneuroimmunological model of health in which psychosocial variables mediate stress and influence health outcomes. Qualitative data showed that social support and positive worldviews were the two themes with the most significant impact on long-term breast cancer survivorship experiences. Survivors expressed a need to advance their health care literacy in order to share ownership of breast cancer and lymphedema treatment decisions. Since breast cancer is an immune-mediated disease, long-term survivorship planning should address psychosocial factors that influence the long-term psychological distress associated with immune dysfunction.

Exploring the usefulness of botanicals as an adjunctive treatment for lymphedema: a systematic search and review.

OBJECTIVES: To provide a critical analysis of the current published research regarding the use, risks, and benefits of botanicals in the treatment of lymphedema and to provide health professionals with current knowledge of safe, appropriate use of botanicals for treatment of lymphedema. TYPE: This systematic search and review addresses the use of botanicals in the treatment of lymphedema in order to develop a best evidence synthesis of the research. LITERATURE SURVEY: Articles were identified from 11 major medical indices published from 2004-2012 using search terms for lymphedema and management. Eighty-five articles met the inclusion criteria of evidence-based lymphedema therapies for the category "complementary and alternative methods for lymphedema therapy." METHODOLOGY: Two clinical lymphedema experts reviewed the studies according to level of evidence guidelines established by the Oncology Nursing Society, Putting Evidence into Practice, and subdivided the methods into subcategories that included Botanical, Pharmaceutical, Physical Agent Modalities, and Modalities of Contemporary Value. The pharmaceutical articles were excluded (5) because they fell outside the inclusion criteria. Twenty-two articles were used in a separate review of physical agent modalities and modalities of contemporary value for lymphedema. Botanicals generated substantial research (11) and warranted its own independent review. SYNTHESIS: The levels of evidence are weak, because research conclusions were limited by size, dose, and study design. A limited number of randomized controlled trials have been performed, and reliability is not always evident, particularly in the context of large systematic reviews where evidence was bundled. CONCLUSIONS: Evidence supporting the use of botanicals for the treatment of lymphedema is insufficient. Some evidence suggests benefits for the treatment of chronic venous insufficiency. Development of specific and sensitive measurement methods may change how botanicals are studied and establish a body of evidence for their use.

Thai nurses' perspectives on the use of complementary and alternative medicine among Thai breast cancer survivors in northern Thailand.

Breast cancer survivors are more likely to seek complementary and alternative medicine (CAM) for their health and well-being than other cancer patients. The purpose of the study was to describe how Thai nurses perceive the use of CAM in Thai breast cancer survivors. An ethno-nursing research method was used. Fifteen Thai nurses who had experience in taking care of Thai breast cancer survivors who used CAM from a tertiary care referral and resource centre in the lower northern part of Thailand were interviewed. Two major themes emerged from this study: Meaning of care practices in CAM was seen as: (i) an additional beneficial choice for health; and (ii) emotional and psychological healing. Nurses should be concerned about CAM use in Thai breast cancer survivors. Open communication about CAM helps ensure that safe and holistic care is provided. Further research to enhance integration of CAM into health care is needed.

Making self-care a priority for women at risk of breast cancer-related lymphedema.

Estimates suggest that between 41% and 94% of breast cancer survivors may develop the chronic condition of secondary lymphedema at some point during their lifetimes. Self-care is critical for effective lymphedema management and risk-reduction. At the same time, women in general have been characterized as engaging in self-sacrificing behaviors in which they choose other-care over self-care. This study explored the self-care experiences of women with breast cancer within the contexts of complex and demanding familial and work-related responsibilities. Participants (N=14) were enrolled in a behavioral-educational intervention aimed at lymphedema risk-reduction. This feminist family theory-informed secondary analysis of qualitative data focused on women's familial roles and the balance or lack of balance between self-sacrifice and self-care. Findings included participants' struggles with time management and prioritizing self-care over care of others as well as making a commitment to self-care. Findings have implications for patient and family-level education and research with regard to gender role-based barriers to self-care and self-care within complex social contexts.

Complementary, alternative, and other noncomplete decongestive therapy treatment methods in the management of lymphedema: a systematic search and review.

OBJECTIVES: (1) To provide a critical analysis of the contemporary published research that pertains to complementary, alternative, and other noncomplete decongestive therapies for treatment of lymphedema (LE), and (2) to provide practical applications of that evidence to improve care of patients with or at risk for LE. TYPE: This study meets the defining criteria as a systematic search and review because it includes varied study types. All studies that met the inclusion criteria were evaluated for weight of evidence and value. LITERATURE SURVEY: The systematic search and review includes articles published in the contemporary literature (2004-2012). Publications published from 2004-2011 were retrieved from 11 major medical indices by using search terms for LE and management approaches. Literature archives were examined through 2012. Data extraction included study design, objectives pertaining to LE, number and characteristics of participants, interventions, and outcomes. Study strengths and weaknesses were summarized. Study evidence was categorized according to the Oncology Nursing Society Putting Evidence into Practice level-of-evidence guidelines after achieving consensus among the authors. No authors participated in development of nor benefitted from the review of these modality methods or devices. METHODOLOGY: Extracted data from 85 studies were reviewed in 4 subcategories: botanical, pharmaceutical, physical agent modality, and modalities of contemporary value. After review, 47 articles were excluded, which left 16 articles on botanicals and pharmaceuticals and 22 articles for physical agent modality and/or modalities of contemporary value. Pharmaceuticals were later excluded. The authors concluded that botanicals had generated sufficient studies to support a second, more specific systematic review; thus, botanicals are reported elsewhere. SYNTHESIS: It was found that limited high-level evidence was available for all categories. Well-constructed randomized controlled trials related specifically to LE were limited. Objective outcome measures over time were absent from several studies. The rationale for the use and benefits of the specific modality, as related to LE, was often anecdotal. Subject numbers were fewer than 50 for most studies. CONCLUSIONS: No interventions were ranked as "recommended for practice" based on the Putting Evidence into Practice guidelines. Two treatment modalities in 3 studies were ranked as "likely to be effective" in reducing LE or in managing secondary LE complications. Consideration should be given that many of the PAMs demonstrate long-standing support within the literature, with broad parameters for therapeutic application and benefit for secondary conditions associated with LE. However, further investigation as to their individual contributory value and the factors that contribute to their efficacy, specific to LE, has not been done. It also is significant to mention that the majority of these studies focused on breast cancer-related LE. Studies that explored treatment interventions for LE-related vascular disorders (eg, chronic venous insufficiency, congenital dysphasia, trauma) were sparse. Limitations of the literature support the recommendations for future research to further examine the level of evidence in these modalities for LE management.

Surveillance recommendations in reducing risk of and optimally managing breast cancer-related lymphedema.

Breast cancer survivors are at increased risk for the development of breast cancer-related lymphedema (BCRL), a chronic, debilitating, and disfiguring condition that is progressive and requires lifelong self-management of symptoms. It has been reported that over 40% of the 2.5 million breast cancer survivors in the United States may meet the criteria for BCRL during their lifetimes. Ongoing surveillance, beginning with pre-operative assessment, has been effective in identifying subclinical lymphedema (LE). A prospective model for surveillance is necessary in order to detect BCRL at an early stage when there is the best chance to reduce risk or slow progression. Physical methods for monitoring and assessment, such as circumferential arm measures, perometry, bioimpedance; exercise programs; prophylactic and early-intervention compression garments; and referral for complete decongestive therapy are all interventions to consider in the development of a BCRL surveillance program. In addition, supportive-educative programs and interactive engagement for symptom self-management should also be implemented. The importance of interdisciplinary collaboration is integral to the success of an effective personalized medicine program in breast cancer-related lymphedema surveillance.

Upper extremity lymphedema: presence and effect on functioning five years after breast cancer treatment.

PURPOSE/OBJECTIVE: Our goal was to explore the effects of lymphedema on long-term adjustment among breast cancer survivors, in terms of functioning in important life environments. RESEARCH METHOD/DESIGN: Limb volume measurements and psychosocial survey data were collected from women shortly after undergoing surgical intervention for breast cancer and annually thereafter. A subset of these women were selected for the current study because they had preoperative limb volume measurement data, which is best suited to determine presence and severity of lymphedema. Our final sample of 61 women had both the arm measurements (preoperative and 5-year) and survey data (baseline and 5-year) needed for this study, which comprises a secondary cross-sectional analysis of longitudinal data. A correlational approach was used to explore associations among lymphedema (presence, severity, and whether the participant met the criteria for lymphedema at any assessment point since their treatment for breast cancer) and outcome variables (physical functioning, vocational functioning, social functioning, domestic functioning, and sexual functioning). RESULTS: Each of the three measures of lymphedema was significantly correlated with domestic functioning, but not with functioning in other common environments. CONCLUSIONS/IMPLICATIONS: Long-term breast cancer survivors are at risk for developing secondary conditions, such as lymphedema, to which they must learn to adjust and adapt. Lymphedema may increase risk for compromised functioning in everyday environments, a problem which lies at the heart of rehabilitation. Breast cancer survivorship, therefore, fits well within the scope of a rehabilitation framework.

Using temporal mining to examine the development of lymphedema in breast cancer survivors.

BACKGROUND: Secondary lymphedema is a lifetime risk for breast cancer survivors and can severely affect quality of life. Early detection and treatment are crucial for successful lymphedema management. Limb volume measurements can be utilized not only to diagnose lymphedema but also to track progression of limb volume changes before lymphedema, which has the potential to provide insight into the development of this condition. OBJECTIVES: This study aims to identify commonly occurring patterns in limb volume changes in breast cancer survivors before the development of lymphedema and to determine if there were differences in these patterns between certain patient subgroups. Furthermore, pattern differences were studied between patients who developed lymphedema quickly and those whose onset was delayed. METHODS: A temporal data mining technique was used to identify and compare common patterns in limb volume measurements in patient subgroups of study participants (n = 232). Patterns were filtered initially by support and confidence values, and then t tests were used to determine statistical significance of the remaining patterns. RESULTS: Higher body mass index and the presence of postoperative swelling are supported as risk factors for lymphedema. In addition, a difference in trajectory to the lymphedema state was observed. DISCUSSION: The results have potential to guide clinical guidelines for assessment of latent and early-onset lymphedema.

Complementary and alternative medicine and lymphedema.

OBJECTIVES: To review the evidence for the effectiveness of complementary and alternative medicine (CAM) on cancer-related lymphedema. DATA SOURCES: CINAHL, PsycINFO, and PubMed (1990-2012). CONCLUSION: To date, there is insufficient evidence to draw conclusions about the benefits of CAM use for cancer patients with lymphedema. Although some CAM types may offer positive effects for the management of lymphedema, negative adverse effects have also been observed. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses and therapists should be aware of and ready to educate cancer patients about the potential effects of CAM. A conversation about the potential risks and benefits of CAM use should be provided.

Management of lymphedema for cancer patients with complex needs.

OBJECTIVES: The purpose of this paper was to discuss the management of lymphedema in patients with advanced disease. DATA SOURCES: Peer-reviewed literature. CONCLUSION: Management of lymphedema in patients with advanced cancer is complex because of multi-factorial issues. Basic components of skin care, compression, massage, and exercise can be applied for these patients. Key concepts are: 1) optimizing quality of life, 2) respecting patients' choices, and 3) providing psychological support to the patients and their families. IMPLICATIONS FOR NURSING PRACTICE: Management plans for patients with lymphedema in advanced disease should be flexible. Holistic and collaborative approaches are essential to achieve the goal of caring for these patients.

Best Practice Guidelines in Assessment, Risk Reduction, Management, and Surveillance for Post-Breast Cancer Lymphedema.

Breast cancer-related lymphedema (LE) is a progressive, chronic disease that affects millions of cancer survivors and primarily results from surgical lymphatic vessel/node removal and radiation therapy. Patient education and support for importance of early detection is essential in helping health care providers detect lymphedema early, when there is the best chance to prevent progression. Improved imaging and surgical techniques have decreased the incidence of LE; however, effective risk-reduction and treatment have historically lacked the level of evidence necessary to standardize effective treatment. The purpose of this article is to report an extensive review of literature, including highlighted multidisciplinary studies within the past three years, in order to update best practice guidelines in assessment, risk reduction, management, and surveillance for post-breast cancer lymphedema.

Psychosocial impact of lymphedema: a systematic review of literature from 2004 to 2011.

OBJECTIVE: This systematic review aimed to evaluate the level of evidence of contemporary peer-reviewed literature published from 2004 to 2011 on the psychosocial impact of lymphedema. METHODS: Eleven electronic databases were searched and 1311 articles retrieved; 23 met inclusion criteria. Twelve articles utilized qualitative methodology and 11 used quantitative methodology. An established quality assessment tool was used to assess the quality of the included studies. RESULTS: The overall quality of the 23 included studies was adequate. A critical limitation of current literature is the lack of conceptual or operational definitions for the concept of psychosocial impact. Quantitative studies showed statistically significant poorer social well-being in persons with lymphedema, including perceptions related to body image, appearance, sexuality, and social barriers. No statistically significant differences were found between persons with and without lymphedema in the domains of emotional well-being (happy or sad) and psychological distress (depression and anxiety). All 12 of the qualitative studies consistently described negative psychological impact (negative self-identity, emotional disturbance, and psychological distress) and negative social impact (marginalization, financial burden, perceived diminished sexuality, social isolation, perceived social abandonment, public insensitivity, and non-supportive work environment). Factors associated with psychosocial impact were also identified. CONCLUSIONS: Lymphedema has a negative psychosocial impact on affected individuals. The current review sheds light on the conceptualization and operationalization of the definitions of psychosocial impact with respect to lymphedema. Development of a lymphedema-specific instrument is needed to better characterize the impact of lymphedema and to examine the factors contributing to these outcomes in cancer and non-cancer-related populations.