Prospective surveillance model in the home for breast cancer-related lymphoedema: a feasibility study
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SUBMITTER: Koelmeyer L
PROVIDER: S-EPMC7529356 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Project description:BackgroundLymphoedema is a chronic condition that causes swelling in the body tissues. Presently, there is no cure for lymphoedema; instead, current treatment is aimed at lifelong management to help control symptoms. Intermittent pneumatic compression (IPC) therapy can be considered as an adjunct to standard lymphoedema care; however, research regarding the efficacy of this treatment modality is limited.MethodsTwenty participants were recruited from an outpatient lymphoedema clinic (South Wales, UK) to a feasibility randomised control trial designed to evaluate the efficacy of an IPC device (LymphAssist, Huntleigh Healthcare) in reducing lower limb volume. The primary objective was to assess feasibility in terms of (1) study feasibility, including recruitment, retention and assessment of outcome measures, and (2) intervention feasibility, including intervention fidelity and acceptability to participants. Participants were randomly assigned to a control group (n = 10) or intervention group (n = 10). The control group received their standard lymphoedema care only for a 6-month period, whereas the intervention group received their standard lymphoedema care plus an IPC device to use for 6 months. A bilateral lower limb assessment and quality of life survey were undertaken at baseline and 3- and 6-month time points.ResultsThe study recruited to target within the planned time frame with a retention rate of 80%. Issues relating to potential recruitment bias and study attrition were identified and possible solutions explored. In addition, supplementary primary outcome measures that are important to the study population were identified and will be incorporated into the design of future studies.ConclusionThis feasibility study identified that a larger randomised controlled trial investigating the efficacy of home use IPC devices is feasible with modifications to the study protocol.Trial registrationThis trial is registered with clinicaltrials.gov (NCT03825263).
| S-EPMC6767651 | biostudies-literature
Project description:Lymphoedema is a common and troublesome condition that develops following breast cancer treatment. The aim of this study is to analyze the effectiveness of Manual Lymphatic Drainage in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema and evaluate the improvement of the concomitant symptomatology.A randomized, controlled clinical trial in 58 women with post-mastectomy lymphoedema. The control group includes 29 patients with standard treatment (skin care, exercise and compression measures, bandages for one month and, subsequently, compression garments). The experimental group includes 29 patients with standard treatment plus Manual Lymphatic Drainage. The therapy will be administered daily for four weeks and the patient's condition will be assessed one, three and six months after treatment.The primary outcome parameter is volume reduction of the affected arm after treatment, expressed as a percentage. Secondary outcome parameters include: duration of lymphoedema reduction and improvement of the concomitant symptomatology (degree of pain, sensation of swelling and functional limitation in the affected extremity, subjective feeling of being physically less attractive and less feminine, difficulty looking at oneself naked and dissatisfaction with the corporal image).The results of this study will provide information on the effectiveness of Manual Lymphatic Drainage and its impact on the quality of life and physical limitations of these patients.ClinicalTrials (NCT): NCT01152099.
| S-EPMC3065438 | biostudies-literature
Project description:PurposeBreast cancer patients undergoing axillary lymph node dissection (ALND) are at risk of lymphedema (LE). Successful management of LE relies on early diagnosis using sensitive modalities. In the current study, we explored the effectiveness of a surveillance program for lymphedema management (SLYM) compared to standard care.MethodsBreast cancer patients who underwent ALND in Seoul National University Bundang Hospital from January 2008 to December 2015 were included in this prospective study. The SLYM commenced in May 2011. The LE outcomes of patients treated prior to initiation of the SLYM were compared with those of patients after SLYM implementation.ResultsA total of 707 patients were included, 390 in the SLYM group and 317 in the historical control (HC) group. A total of 203 patients (28.7 %) had episodes of all-stage LE during follow-up. Of these, 126 (19.7 %) were in the surveillance group and 77 (24.3 %) in the HC group. The overall 5-year cumulative incidence of LE (greater than stage 3) was 25 (95 % CI 15.4-34.6) (6.4 %) in the SLYM group and 48 (95 % CI, 15.4-34.6) (15.1 %) in the HC group. In the SLYM group, poor compliance had a significant impact on LE incidence (OR = 2.98, P = 0.002). Low level of self-monitoring and insight scores were significantly related to LE incidence (OR = 1.31, P = 0.025) after adjusting for age, body mass index, the type of surgery chosen, radiation therapy, and chemotherapy. With a cut-off of 29.5 days from operation to the first visit to the LE clinic, the sensitivity was 60 % and the specificity 61 % in terms of predicting a LE event.ConclusionsSurveillance improves LE prevention compared to clinical evaluation. The first visit to the LE clinic should be made within 1 month after surgery. In the first year, visits should be made at intervals of less than 3 months.
| S-EPMC5065580 | biostudies-literature
Project description:The aim of this study was to propose a magnetic resonance imaging acquisition and analysis protocol that uses image segmentation to measure and depict fluid, fat, and muscle volumes in breast cancer-related lymphoedema (BCRL). This study also aims to compare affected and control (unaffected) arms of patients with diagnosed BCRL, providing an analysis of both the volume and the distribution of the different tissue components.The entire arm was imaged with a fluid-sensitive STIR and a 2-point 3-dimensional T1W gradient-echo-based Dixon sequences, acquired in sagittal orientation and covering the same imaging volume. An automated image postprocessing procedure was developed to simultaneously (1) contour the external volume of the arm and the muscle fascia, allowing separation of the epifacial and subfascial volumes; and to (2) separate the voxels belonging to the muscle, fat, and fluid components. The total, subfascial, epifascial, muscle (subfascial), fluid (epifascial), and fat (epifascial) volumes were measured in 13 patients with unilateral BCRL. Affected versus unaffected volumes were compared using a 2-tailed paired t test; a value of P < 0.05 was considered to be significant. Pearson correlation was used to investigate the linear relationship between fat and fluid excess volumes. The distribution of fluid, fat, and epifascial excess volumes (affected minus unaffected) along the arm was also evaluated using dedicated tissue composition maps.Total arm, epifascial, epifascial fluid, and epifascial fat volumes were significantly different (P < 0.0005), with greater volume in the affected arms. The increase in epifascial volume (globally, 94% of the excess volume) constituted the bulk of the lymphoedematous swelling, with fat comprising the main component. The total fat excess volume summed over all patients was 2.1 times that of fluid. Furthermore, fat and fluid excess volumes were linearly correlated (Pearson r = 0.75), with the fat excess volume being greater than the fluid in 11 subjects. Differences in muscle compartment volume between affected and unaffected arms were not statistically significant, and contributed only 6% to the total excess volume. Considering the distribution of the different tissue excess volumes, fluid accumulated prevalently around the elbow, with substantial involvement of the upper arm in only 3 cases. Fat excess volume was generally greater in the upper arm; however, the relative increase in epifascial volume, which considers the total swelling relative to the original size of the arm, was in 9 cases maximal within the forearm.Our measurements indicate that excess of fat within the epifascial layer was the main contributor to the swelling, even when a substantial accumulation of fluid was present. The proposed approach could be used to monitor how the internal components of BCRL evolve after presentation, to stratify patients for treatment, and to objectively assess treatment response. This methodology provides quantitative metrics not currently available during the standard clinical assessment of BCRL and shows potential for implementation in clinical practice.
| S-EPMC5548500 | biostudies-other
Project description:IntroductionOver the last decades, treatment of breast cancer has become increasingly more effective. Consequently, an increasing number of women are living with late effects of breast cancer treatment, including disfiguring scars, deformity or asymmetry of the breast, secondary lymphoedema and other physical and psychosocial late effects. Data from this study will provide knowledge on how to guide breast reconstruction in the future towards outcomes with fewer complications, higher long-term quality of life (QoL) and satisfaction with the aesthetic outcome. The development of secondary lymphoedema, for which the effect of breast reconstruction has yet to be established, will be thoroughly examined.Methods and analysisWomen receiving breast reconstruction (autologous and implant based) at the Department of Plastic Surgery and Burns Treatment, Rigshospitalet, will be invited to participate. The patients will be followed for 10 years postoperatively. Demographic, health-related, oncological characteristics and treatment data will be registered. Validated assessment tools, such as the BREAST-Q and Beck Depression Inventory, will be used to measure an extensive range of clinical outcomes, including QoL, life and aesthetic satisfaction and depression. Arm range of motion will be measured with a goniometer and lymphoedema by bioimpedance spectroscopy, compared with circular arm measurements.Ethics and disseminationThis study will be conducted according to the 5th version of the Helsinki Declaration. The regional ethical committee for Capital Region Denmark did not find the study notifiable, according to the law of the committee § 1, part 4. All data will be anonymised before its publication. This study will be conducted according to the Danish data protection regulation and is catalogued and approved by the Capital Region Head of Knowledge Centre. According to the Danish health law § 46, part 2, this study does not need the Danish Patient Safety Authority's approval. The findings of this study will be submitted to international peer-reviewed journals.
| S-EPMC8650483 | biostudies-literature
Project description:Background: Breast cancer-related lymphedema (BCRL) is hard to control. Management may include lymphatic drainage, skin care, bandaging, or even surgery. Since acupuncture has been proven to affect the neurophysiology and neuroendocrine systems, it has the potential to control BCRL. Aim: To evaluate the effect of acupuncture in BCRL in randomized controlled trials. Design: A literature search was performed, following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement and without language restrictions. Data Sources: Five databases were searched from inception tthrough September 2018. Only studies that fulfilled the eligibility criteria of evaluating the effect of acupuncture on lymphedema in breast cancer were included. The methodological quality of these trials was assessed using the Cochrane criteria, and meta-analysis software (RevMan 5.3) was used for analysis. Results: We examined 178 breast cancer patients from 6 trials. All included randomized controlled trials had medium to high quality, based on the modified Jadad scale. The systematic review showed that acupuncture is safe and has a trend to improve symptoms, but trials did not consistently measure outcomes. The meta-analysis showed that acupuncture produced no significant improvement in the extent of lymphedema as compared with the control intervention (-1.90; 95% confidence interval = -5.39 to 1.59, P = .29). None of the studies reported severe adverse events. Conclusions: Acupuncture is safe and has a trend to improve the lymphedema related to breast cancer, yet it did not significantly change arm circumference in BCRL. Future studies should include both subjective and objective measurements and large-scale studies are warranted.
| S-EPMC6686319 | biostudies-literature
Project description:Background:There is a need to reduce unnecessary general practitioner (GP) consultations and improve antibiotic stewardship in primary care. Respiratory tract infections (RTIs) in children are the most common reason for consulting and prescribing. Most RTI research is conducted at the point of consultation, leaving a knowledge gap regarding the population burden of RTIs. Methods:Community-based, online prospective inception cohort study with nested qualitative study, to evaluate the feasibility and acceptability of collecting RTI symptom and microbiological data from children recruited prior to RTI onset. Results:Parents of 10,310 children were invited. Three hundred thirty-one parents of 485 (4.7%) children responded and completed baseline data. Respondents were less socioeconomically deprived (p?<?0.001) with younger (median ages 4 vs. 6?years, p?<?0.001) children than non-respondents. The same parents reported 346 RTI episodes in 259 children, and 305 RTIs (in 225 children) were retained to parent-reported symptom resolution. Restricting analyses to the first RTI episode per family (to account for clustering effects), parents fully completed symptom diaries for 180 (87%) of 192 first illness episodes. Research nurses conducted home visits for 199 RTI episodes, collecting complete (symptomatic) swab sets in 195 (98%). Parents collected 194 (98% of 199 possible) symptomatic (during the nurse visit) and 282 (92% of 305 possible) asymptomatic swab sets (on symptom resolution, no nurse present). Interviews with 30 mothers and 11 children indicated study acceptability. Conclusions:Invitation response rates were in the expected range. The high retention and qualitative evidence suggest that community-based paediatric syndromic and microbiological surveillance research is feasible.
| S-EPMC6287344 | biostudies-literature
Project description:ObjectiveTo explore the perceived unmet needs among women treated for breast cancer and in whom symptoms and signs indicate the presence of lymphoedema.DesignPopulation based cross sectional survey with a purpose designed questionnaire (60 items).SettingCancer registries of New South Wales, Victoria, and South Australia.Participants237 women with symptoms and signs indicative of lymphoedema from an initial 1930 eligible women.Main outcome measureUnmet needs in the previous month across psychological, health system and information, physical and daily living, patient care and support, sexuality needs, body image, and financial domains.ResultsThe 10 items most commonly identified as a "moderate to high current need" included having their doctor and allied health workers being fully informed about lymphoedema, acknowledge the seriousness of the condition, and be willing to treat it. Women also wanted access to up to date treatments, both mainstream and alternative, and financial assistance for their garments. The three factors that explained most of the variance were: information and support (11 items), which accounted for 49% of the variance; body image and self esteem (seven items; 7% variance); and health system (seven items; 5% variance). Examination of these three factors showed that while the levels of need were generally low, they were common.ConclusionTo address the needs of women with lymphoedema and perhaps to prevent progression of lymphoedema, it is important that practitioners do not dismiss mild symptoms and that women are referred to an appropriate specialist.
| S-EPMC3119382 | biostudies-literature
Project description:IntroductionBreast-cancer-related upper extremity lymphoedema (BCUL), a common complication of mastectomy, can cause physical discomfort, psychological distress, cosmetic defects, functional disability and chronic recurrent erysipelas in the affected arm(s). It is a challenge to physicians involved in the management of these patients. Wuling San, a classic prescription in Traditional Chinese Medicine used in treating oedema for thousands of years, is reported by many Chinese journals to perform well in BCUL. Therefore, the aim of this study is to verify its efficacy and evaluate its safety using rigorous methodological designs in patients with BCUL.Methods and analysisTo verify the efficacy and assess the safety of Wuling San over a placebo, this double-blind, randomised, placebo-controlled, multicentre trial will be carried out in three hospitals. A total of 200 eligible patients with BCUL will be randomly allocated, in a ratio of 1:1, to either the experimental medicine group or the placebo group. The primary outcome measure will be the proportion of absolute reduced limb volume, as measured by perometry. The second outcome measure will be the number of participants with adverse events. The assessment will be carried out at the following time points: before enrolment (baseline) and 2, 4, 6 and 8 weeks after treatment.Ethics and disseminationThis trial will be conducted in accordance with the Declaration of Helsinki and supervised by the institutional review board of the Fourth Affiliated Hospital of Guangxi Medical University (approval number PJK2016088). All patients will receive information about the trial in verbal and written forms and will give informed consent before enrolment. This trial will help to demonstrate whether Wuling San is effective in the treatment of patients with BCUL. The results will be published in peer-reviewed journals or disseminated through conference presentations.Trial registration numberNCT02726477; Pre-results.
| S-EPMC5168680 | biostudies-literature
Project description:ObjectiveThe objectives of this study were to determine whether patients reporting symptoms are more likely to develop lymphedema and to describe the temporal relationship between symptom onset and lymphedema.MethodsThis was a prospective longitudinal cohort study of 647 women treated for breast cancer and screened for lymphedema using arm volume measurements and subjective questionnaires (n = 647; 2284 questionnaires [median 3.5 per patient, range = 1-24]). Primary study outcome was lymphedema (relative volume change ≥10%). The Kaplan-Meier method was used to estimate cumulative lymphedema incidence. Cox proportional hazards models were used to assess the relationship between symptoms, other risk factors, and lymphedema.ResultsA total of 64 patients (9.9%) developed lymphedema. On multivariable analysis, patients reporting increased arm size (hazard ratio = 3.09, 95% CI = 1.62-5.89) were more likely to progress to lymphedema than those who did not report this symptom. Of those who developed lymphedema, 37 (58%) reported an increased arm size a median of 6.1 months before lymphedema onset (range = 68.6 months before to 50.2 months after lymphedema onset).ConclusionPatients at risk of lymphedema who report increased arm size might do so prior to lymphedema onset and are at 3 times the risk of lymphedema as patients not reporting this symptom. Even without objective or observable edema, these patients should be followed vigilantly and considered for early intervention. Symptoms should be incorporated into screening and diagnostic criteria for lymphedema.ImpactThis study shows that patients at risk for breast cancer-related lymphedema who report increased arm size should be considered at high risk for progression to lymphedema-even without edema on measurement or clinical examination-and should be followed vigilantly, with consideration of early intervention.Lay summaryIf you are at risk of lymphedema and you feel as though your arm size has increased, you might develop lymphedema, and you are at 3 times the risk of lymphedema as patients not reporting this symptom. Even without measurable or observable edema, you should be followed vigilantly and consider early intervention.
| S-EPMC7824870 | biostudies-literature