Reliability, concurrent validity, and clinical feasibility of measurement methods determining volume in patients with lower limb lymphedema and healthy controls.

PURPOSE: To investigate reliability, concurrent validity, and clinical feasibility of measurements assessing volume in patients with lower limb lymphedema (LLL) and healthy controls. MATERIALS AND METHODS: To investigate intra- and interrater reliability, 47 patients with LLL and 30 healthy controls were assessed three times by two assessors. To investigate between session reliability, 50 participants were reassessed two weeks later. Each assessment included measurements of the midline region (hip circumference; suprapubic volume), leg volume (perimeter every 4 cm; Perometer®), and foot volume (water displacement; figure-of-eight method). Concurrent validity was assessed with correlation coefficients. Measurements were timed and practical limitations were reviewed. Clinical trial registration number: NCT: 05269264. RESULTS: Measurements of the total volume of different regions showed weak to very high intraclass correlation coefficients (ICCs) (0.131-998). Absolute and relative volume differences had lower ICC values (0.360-0.976). A strong correlation was found between the total volumes of the same region. The Perometer® and figure-of-eight method were the fastest method for leg and foot volume, respectively. CONCLUSIONS: The assessed total volumes might be more valuable in assessing the evolution of volume in bilateral LLL than the calculated absolute and relative differences between both limbs. The Perometer® and figure-of-eight method were the most time efficient for leg and foot volume, respectively.Implications for rehabilitationLymphedema is a chronic condition for which a reliable and clinically feasible assessment of volume is essential for the diagnosis, treatment decisions, and the evaluation of the treatment.This study shows that the total leg/foot volumes were more reliable than the calculated absolute and relative differences between both limbs and could therefore more valuable to evaluate bilateral lower limb lymphedema.For the assessment of leg volume, the Perometer® was the most reliable and fastest method.For the evaluation of the foot volume, the figure-of-eight method was overall the best method.

Accuracy of consumer-based activity trackers to measure and coach patients with lower limb lymphoedema.

PURPOSE: This study investigated the accuracy of activity trackers in chronic lower limb lymphoedema (LLL) patients and in comparison to matched controls. MATERIALS AND METHODS: Seventeen LLL patients and 35 healthy subjects wore an activity tracker at the hip (Fitbit Zip/Inspire; hip-AT) and one at the wrist (Fitbit Alta/Inspire; wrist-AT) combined with a reference activity monitor (Dynaport Movemonitor; DAM), for 14 consecutive days. To analyze accuracy and agreement, mean daily step count from both AT's were compared to DAM. To evaluate the accuracy as coaching tool, day-by-day differences were calculated. The Kendall correlation coefficient was used to test consistency of ranking daily steps between the AT's and the DAM. RESULTS: The wrist-AT significantly overestimated daily step count compared to DAM in the LLL group (+1221 ± 1754 steps per day, p = 0.011) while the hip-AT underestimated the step count, although not significantly. Similar results were found in the healthy control group. As a coaching tool, both wrist-AT and hip-AT showed a moderate correlation with the DAM (r = 0.507 and 0.622, respectively) in the LLL group regarding consistency of ranking from most to least active days. CONCLUSION: Wrist-AT's significantly overestimate daily step count in a LLL population. As a coaching tool, both trackers show moderate validity, indicating applicability to improve physical activity.

Reply to Bourgeois, P. Comment on "Devoogdt et al. The Effectiveness of Fluoroscopy-Guided Manual Lymph Drainage as Part of Decongestive Lymphatic Therapy on the Superficial Lymphatic Architecture in Patients with Breast Cancer-Related Lymphoedema: A Randomised Controlled Trial. Cancers 2023, 15, 1545".

We appreciate the commentary by Pierre Bourgeois [...].

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Accuracy of consumer-based activity trackers as measuring tool and coaching device in breast and colorectal cancer survivors.

PURPOSE: Consumer-based activity trackers are used to measure and promote PA. We studied the accuracy of a wrist- and waist-worn activity tracker in cancer survivors and compared these results to a healthy age-matched control group. METHODS: Twenty-two cancer survivors and 35 healthy subjects wore an activity tracker at the waist and at the wrist combined with a reference activity monitor at the waist (Dynaport Movemonitor). The devices were worn for 14 consecutive days. The mean daily step count from both activity trackers was compared with the reference activity monitor to investigate accuracy and agreement (paired t-test, intraclass correlation, Bland-Altman plots). To evaluate the accuracy as a coaching tool, day-by-day differences within patients were calculated. The Kendall correlation coefficient was used to test the consistency of ranking daily steps between the activity trackers and the reference activity monitor. RESULTS: The wrist-worn wearable significantly overestimated the daily step count in the cancer group (mean ± SDΔ: + 1305 (2685) steps per day; p = 0.033) and in the healthy control group (mean ± SDΔ: + 1598 (2927) steps per day; p = 0.003). The waist-worn wearable underestimated the step count in both groups, although this was not statistically significant. As a coaching device, moderate (r = 0.642-0.670) and strong (r = 0.733-0.738) accuracy was found for the wrist- and waist-worn tracker, respectively, for detecting day-by-day variability in both populations. CONCLUSION: Our results show that wrist-worn activity trackers significantly overestimate daily step count in both cancer survivors and healthy control subjects. Based on the accuracy, in particular, the waist-worn activity tracker could possibly be used as a coaching tool.

Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education.

PURPOSE: The aim of this study was to investigate the effect of pain neuroscience education compared to biomedical pain education after breast cancer surgery on (1) work status, (2) time until work resumption, and (3) change in return-to-work expectations up to 18 months post-surgery. METHODS: Participants were randomly assigned to either pain neuroscience education (intervention group) or biomedical pain education (control group) in addition to a standard physical therapy program after surgery for breast cancer. The first four months following surgery, one to two physiotherapy sessions and three educational sessions were scheduled. After, two educational sessions and two physiotherapy sessions were held at six and eight months postoperatively. All outcomes were assessed at four, six, eight, 12 and 18 months postoperatively. RESULTS: At 12 months, in the intervention group, 71% of the women returned to work compared to 53% in the control group (18% points difference, 95%CI:-0.1 to 35;p = 0.07). At 18 months, the differences decreased to 9% points, 95%CI:-26 to 7;p = 0.35). Neither time until work resumption (p = 0.46) nor change in estimation of own ability to return to work up to 18 months postoperatively (p = 0.21) significantly differed between both groups. CONCLUSION: No significant differences were found regarding return to work outcomes between women receiving pain neuroscience education versus biomedical pain education after breast cancer surgery. Further research is warranted to explore the potential role of pain neuroscience education in return-to-work interventions following breast cancer surgery.

EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life.

BACKGROUND: With over 500,000 annually reported cases worldwide, head and neck cancer (HNC) is the seventh most common type of cancer worldwide. Treatment of HNC with chemoradiotherapy frequently results in serious impairments in physical and psychosocial functioning. Besides, HNC patients typically start their cancer treatment already with poor physical and psychosocial health. It has been shown that a sufficient level of physical activity (PA) before, during, and after cancer treatment is associated with fewer negative treatment-related side effects and a better quality of life (QOL). In order to prevent worsening of functioning and limit the physical impact of the HNC treatment, a comprehensive supervised exercise program (CSEP) may be beneficial during early cancer treatment. However, up to now, the feasibility and effectiveness of such a program are not yet investigated thoroughly in HNC. Therefore, the primary objective of this study is to examine the effectiveness of a CSEP during HNC treatment, in addition to usual supportive care, compared to usual supportive care alone, on health-related QOL up to 1 year post-diagnosis. Secondary objectives entail gathering information on (1) the effectiveness of a CSEP on secondary outcomes such as physical and mental function, activities of daily life, and participation in society and (2) the feasibility, possible barriers, and facilitators for participation in a CSEP during HNC treatment. METHODS: To investigate the effectiveness of the CSEP, a parallel, open-label randomized controlled trial will be performed. To study the feasibility of the CSEP, a mixed-method study will be performed in a subgroup of participants. HNC patients are eligible if they receive radiotherapy at the Radiation-Oncology department of the University Hospital of Leuven. A 4-size permuted block randomization will be used. The control group receives the current standard of supportive care. The intervention group receives a CSEP, additional to the same usual supportive care. The CSEP consists of a 12-week intensive phase with 3 exercise sessions of 1 h per week, where supervision is gradually reduced after 6 weeks. During the maintenance phase (from week 13), patients exercise at home with monthly tele-consultations with a physiotherapist. The CSEP contains supervised aerobic and resistance training. In both groups, outcomes of interest are evaluated through self-reported questionnaires and clinical assessments, at baseline, 6 weeks, 12 weeks, 6 months, and 12 months post-diagnosis. The primary endpoint is health-related QOL, measured with the EORTC QLQ-C30 at 6 months post-diagnosis. DISCUSSION: The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals Leuven (s65549). Recruitment started in January 2022. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov Identifier: NCT05256238 Date of registration: February 25, 2022.

The effect of myofascial and physical therapy on trunk, shoulder, and elbow movement patterns in women with pain and myofascial dysfunctions after breast cancer surgery: Secondary analyses of a randomized controlled trial.

INTRODUCTION: Secondary upper limb dysfunctions are common after breast cancer treatment. Myofascial treatment may be a valuable physical therapy modality for this problem. OBJECTIVE: To investigate the effect of myofascial therapy in addition to physical therapy on shoulder, trunk, and elbow movement patterns in women with pain and myofascial dysfunctions at the upper limb after breast cancer surgery. DESIGN: A double-blinded randomized controlled trial. SETTING: Rehabilitation unit of a university hospital. PARTICIPANTS: Forty-eight women with persistent pain after finishing breast cancer treatment. INTERVENTIONS: Over 3 months, all participants received a standard physical therapy program. The experimental (n = 24) and control group (n = 24) received 12 additional sessions of myofascial therapy or placebo therapy, respectively. MAIN OUTCOME MEASURES: Outcomes of interest were movement patterns of the humerothoracic joint, scapulothoracic joint, trunk, and elbow, measured with an optoelectronic measurement system during the performance of a forward flexion and scaption task. Statistical parametric mapping (SPM) analyses were used for assessing the effect of treatment on movement patterns between both groups (group × time interaction effect). RESULTS: A significantly decreased protraction and anterior tilting was found after experimental treatment. No beneficial effects on movement patterns of the humerothoracic joint, trunk, or elbow were found. CONCLUSION: Myofascial therapy in addition to a 12-week standard physical therapy program can decrease scapular protraction and anterior tilting (scapulothoracic joint) during arm movements. Given the exploratory nature of these secondary analyses, the clinical relevance of these results needs to be investigated further.

The Effectiveness of Fluoroscopy-Guided Manual Lymph Drainage as Part of Decongestive Lymphatic Therapy on the Superficial Lymphatic Architecture in Patients with Breast Cancer-Related Lymphoedema: A Randomised Controlled Trial.

The objective of this trial was to investigate the effectiveness of fluoroscopy-guided manual lymph drainage (MLD), as part of decongestive lymphatic therapy (DLT), on the superficial lymphatic architecture in patients with chronic mild to moderate breast cancer-related lymphoedema (BCRL). This trial was a multicentre, double-blind, randomised controlled trial involving 194 participants with BCRL. Participants were randomised into (1) DLT with fluoroscopy-guided MLD (intervention group), (2) DLT with traditional MLD (control group), or (3) DLT with placebo MLD (placebo group). Superficial lymphatic architecture was evaluated as a secondary outcome, visualised by ICG lymphofluoroscopy at the baseline (B0), post-intensive (P), and post-maintenance phases (P6). Variables were (1) number of efferent superficial lymphatic vessels leaving the dermal backflow region, (2) total dermal backflow score, and (3) number of superficial lymph nodes. The traditional MLD group showed a significant decrease in the number of efferent superficial lymphatic vessels at P (p = 0.026), and of the total dermal backflow score at P6 (p = 0.042). The fluoroscopy-guided MLD and placebo group showed significant decreases in the total dermal backflow score at P (p < 0.001 and p = 0.044, respectively) and at P6 (p < 0.001 and p = 0.007, respectively); the placebo MLD group showed a significant decrease in the total number of lymph nodes at P (p = 0.008). However, there were no significant between-group differences for the changes in these variables. In conclusion, based on lymphatic architecture outcomes, the added value of MLD, in addition to the other parts of DLT, could not be demonstrated in patients with chronic mild to moderate BCRL.

Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial).

ABSTRACT: Pain is one of the most common and long-lasting side effects reported by women surgically treated for breast cancer. Educational interventions may optimize the current physical therapy modalities for pain prevention or relief in this population. Pain neuroscience education (PNE) is an educational intervention that explains the pain experience not only from a biomedical perspective but also the psychological and social factors that contribute to it. Through a double-blinded randomized controlled trial (EduCan trial) it was investigated if PNE, in addition to the standard physiotherapy program immediately after breast cancer surgery, was more effective over the course of 18 months postoperatively than providing a biomedical explanation for pain. Primary outcome was the change in pain-related disability (Pain Disability Index, 0-70) over 12 months. Secondary outcomes included change in pain intensity, upper limb function, physical activity level, and emotional functioning over 4, 6, 8, 12, and 18 months postoperatively. Multivariate linear models for repeated (longitudinal) measures were used to compare changes. Preoperative and postoperative moderators of the change in pain-related disability were also explored. Of 184 participants randomized, the mean (SD) age in the PNE and biomedical education group was 55.4 (11.5) and 55.2 (11.4) years, respectively. The change in pain-related disability from baseline to 12 months postoperatively did not differ between the 2 groups (PNE 4.22 [95% confidence interval [CI]: 1.40-7.03], biomedical 5.53 [95% CI: 2.74-8.32], difference in change -1.31 [95% CI: -5.28 to 2.65], P = 0.516). Similar results were observed for all secondary outcomes. Future research should explore whether a more patient-tailored intervention would yield better results.

Questionnaire-based somatosensory profiling in breast cancer survivors: are we there yet? Associations between questionnaires and quantitative sensory testing.

PURPOSE: Pain and sensory disturbances are common side effects of breast cancer treatment. Differential somatosensory functioning may reflect distinct pathophysiological backgrounds and therapeutic needs. Aim was to examine whether questionnaires evaluating signs and symptoms related to somatosensory functioning correlate sufficiently with quantitative sensory testing (QST) in breast cancer survivors to warrant consideration for somatosensory profiling in clinical practice. METHODS: One year after breast cancer surgery, 147 women underwent QST and completed following questionnaires: Douleur Neuropathique en 4 questions (DN4), Central Sensitization Inventory, Margolis Pain Diagram and Visual Analog Scales (VAS). Associations between the questionnaires and QST were evaluated using Spearman correlation coefficients (rs). RESULTS: Significant but weak (rs < 0.30) correlations were found between total DN4 score and QST results at the inner upper arm for detection of sharp stimuli (rs = 0.227), cold stimuli (rs = -0.186), and painful heat stimuli (rs = 0.179), as well as between QST evaluating conditioned pain modulation and the Margolis Pain Diagram on one hand (rs = 0.176) and minimum-maximum pain intensity differences (VAS) on the other (rs = -0.170). CONCLUSION: Questionnaires evaluating signs and symptoms related to somatosensory functioning are insufficient for somatosensory profiling. Although somatosensory profiling may be valuable in a mechanism-based management, more research on the most appropriate clinical tools is needed.IMPLICATIONS FOR REHABILITATIONClinicians should be able to recognize that patients with persistent pain or sensory disturbances following breast cancer surgery may have a component of altered somatosensory processing as a significant contributor to their complaint in order to address it appropriately.Somatosensory profiling has yet to be implemented into clinical practice.No evidence-based recommendations can be made on the use of self-reported questionnaires to assess somatosensory processing in a breast cancer population based on the findings of this study.It is suggested to combine information on how individuals process and experience somatosensory stimulation with information from the patient interview or questionnaires to consider which biological, psychological and/or social factors may drive or sustain these neurophysiological processes.

The Dutch language version of the Pain Disability Index (PDI-DLV): psychometric properties in breast cancer patients.

BACKGROUND: Pain after breast cancer surgery is a common and disabling problem. A reliable and valid questionnaire to assess pain-related disability is the Pain Disability Index (0-70). However, properties of the Dutch version (PDI-DLV) have never been investigated in this population. OBJECTIVE: To assess psychometric properties of the PDI-DLV after breast cancer surgery. METHODS: For reliability, relative and absolute reliability were calculated with a one-week test-retest interval, as well as internal consistency. Moreover, content and construct validity were examined to evaluate validity. RESULTS: One hundred twenty-three women were included. Relative reliability was good (intraclass correlation coefficient = 0.80). Standard error of measurement and minimal detectable change (absolute reliability) were 5.57 and 15.45 points, respectively. The mean difference between two measurements was -1.98 points, with 95% limits of agreement equal to 13.19 and -17.15. The within-subjects coefficient of variation was 59%. Internal consistency was confirmed (α = 0.87). The PDI-DLV was scored as understandable and complete (content validity). Construct validity was supported by confirmation of more than 75% of the tested hypotheses and of the one-factor model. CONCLUSION: The PDI-DLV is a valid questionnaire to assess pain-related disability 1 year after breast cancer surgery. Although absolute reliability is disputable, its good relative reliability allows evaluating changes between subjects.

Pain prevalence and characteristics in survivors of solid cancers: a systematic review and meta-analysis.

PURPOSE: The latest systematic review on the prevalence of pain in cancer survivors was published 5 years ago. The current review aims to provide an extended overview on the prevalence of pain, pain mechanisms, pain characteristics, and assessment methods in cancer survivors. METHODS: A systematic research was conducted on 17th of April 2020 using MEDLINE, Embase, Scopus, Web of Science, and Cochrane looking at studies from 2014 to 2020. Studies had to report pain prevalence rates in cancer survivors with a solid tumor who finished curative treatment at least 3 months ago. Methodological quality was assessed by two independent reviewers using the Joanna Briggs Institute quality appraisal tool. Characteristics of the included studies, participants and reported pain prevalence rates were extracted. The reported prevalence rates of the individual studies were pooled within a meta-analysis. Meta-regressions were performed to identify possible determinants of the pooled pain prevalence. RESULTS: After deduplication, 7300 articles were screened, after which 38 were included in the meta-analysis. Risk of bias was rated low in 26 articles and moderate in 12 articles. The pooled pain prevalence was 47% (95%CI 39-55), with a heterogeneity of 98.99%. CONCLUSION: This meta-analysis suggests that nearly half of cancer survivors report pain after completing curative treatment at least 3 months ago. However, substantial unexplained heterogeneity warrants cautious interpretation of these results. Meta-regression using cancer type, treatment location, pain measurement, and follow-up time as a covariate could not explain influencing factors explaining the high heterogeneity.

Does Manual Lymphatic Drainage Add Value in Reducing Suprafascial Fluid Accumulation and Skin Elasticity in Patients With Breast Cancer-Related Lymphedema?

OBJECTIVE: The purpose of this study was to investigate the effectiveness of fluoroscopy-guided manual lymph drainage (MLD) versus that of traditional and placebo MLD, when added to decongestive lymphatic therapy (DLT) for the treatment of breast cancer-related lymphedema (BCRL) (EFforT-BCRL trial), on the suprafascial accumulation of lymphatic fluid and skin elasticity. METHODS: In this multicenter, 3-arm, double-blind, randomized controlled trial (EFforT-BCRL trial), 194 participants (mean age = 61 [SD = 10] years) with unilateral BCRL were recruited. All participants received standardized DLT (education, skin care, compression therapy, exercises) and were randomized to fluoroscopy-guided, traditional, or placebo MLD. Participants received 60 min/d of treatment during the 3-week intensive phase and 18 sessions of 30 minutes during the 6-month maintenance phase. During this phase, participants were instructed to wear a compression garment, to perform exercises, and to perform a self-MLD procedure once daily. This study comprises secondary analyses of the EFforT-BCRL trial. Outcomes were the amount of fluid accumulation in the suprafascial tissues (local tissue water, extracellular fluid, and thickness of the skin and subcutaneous tissue) and skin elasticity at the level of the arm and trunk. Measurements were performed at baseline; after intensive treatment; after 1, 3, and 6 months of maintenance treatment; and after 6 months of follow-up. RESULTS: At the level of the arm, there was a significant improvement over time in the 3 groups for most of the outcomes. At the level of the trunk, no remarkable improvement was noted within the individual groups. No significant interaction effects (between-group differences) were present. Only skin elasticity at the level of the arm, evaluated through palpation, showed a significant interaction effect. CONCLUSION: All 3 groups showed similar improvements in response to DLT regardless of the type of MLD that was added. The effect of the addition of MLD to other components of DLT for reducing local tissue water and extracellular fluid or skin thickness and for improving skin elasticity and fibrosis in participants with chronic BCRL was limited. IMPACT: Although MLD has been applied all over the world for many years, evidence regarding its added value in reducing arm volume in patients with BCRL is lacking. These results show that adding MLD to other components of DLT has limited value in reducing local tissue water and extracellular fluid or skin thickness and in improving skin elasticity and fibrosis in patients with chronic BCRL. To date, there is no clinical indication to continue including time-consuming MLD in physical therapist sessions for patients with chronic BCRL.

Manual lymphatic drainage with or without fluoroscopy guidance did not substantially improve the effect of decongestive lymphatic therapy in people with breast cancer-related lymphoedema (EFforT-BCRL trial): a multicentre randomised trial.

QUESTIONS: When added to decongestive lymphatic therapy (DLT), what is the effect of fluoroscopy-guided manual lymphatic drainage (MLD) versus traditional MLD or placebo MLD for the treatment of breast cancer-related lymphoedema (BCRL)? DESIGN: Multicentre, three-arm, randomised controlled trial with concealed allocation, intention-to-treat analysis and blinding of assessors and participants. PARTICIPANTS: At five hospitals in Belgium, 194 participants with unilateral chronic BCRL were recruited. INTERVENTION: All participants received standard DLT (education, skin care, compression therapy and exercises). Participants were randomised to also receive fluoroscopy-guided MLD (n = 65), traditional MLD (n = 64) or placebo MLD (n = 65). Participants received 14 sessions of physiotherapy during the 3-week intensive phase and 17 sessions during the 6-month maintenance phase. Participants performed self-management on the other days. OUTCOME MEASURES: All outcomes were measured: at baseline; after the intensive phase; after 1, 3 and 6 months of maintenance phase; and after 6 months of follow-up. The primary outcomes were reduction in excess volume of the arm/hand and accumulation of excess volume at the shoulder/trunk, with the end of the intensive phase as the primary endpoint. Secondary outcomes included daily functioning, quality of life, erysipelas and satisfaction. RESULTS: Excess lymphoedema volume decreased after 3 weeks of intensive treatment in each group: 5.3 percentage points of percent excessive volume (representing a relative reduction of 23.3%) in the fluoroscopy-guided MLD group, 5.2% (relative reduction 20.9%) in the traditional MLD group and 5.4% (relative reduction 24.8%) in the placebo MLD group. The effect of fluoroscopy-guided MLD was very similar to traditional MLD (between-group difference 0.0 percentage points, 95% CI -2.0 to 2.1) and placebo MLD (-0.2 percentage points, 95% CI -2.1 to 1.8). Fluid accumulated at the shoulder/trunk in all groups. The average accumulation with fluoroscopy-guided MLD was negligibly less than with traditional MLD (-3.6 percentage points, 95% CI -6.4 to -0.8) and placebo MLD (-2.4 percentage points, 95% CI -5.2 to 0.4). The secondary outcomes also showed no clinically important between-group differences. CONCLUSION: In patients with chronic BCRL, MLD did not provide clinically important additional benefit when added to other components of DLT. REGISTRATION: NCT02609724.

Biopsychosocial risk factors for pain and pain-related disability 1 year after surgery for breast cancer.

PURPOSE: Knowledge regarding risk factors for pain in the long term after surgery for breast cancer may be of great value in preventing this prevalent and debilitating side effect. Despite the biopsychosocial nature of pain, the predictive value of both pre- and postoperative biopsychosocial functioning for long-term pain intensity and pain-related disability has not yet been studied. METHODS: One hundred sixty-six women planned for unilateral breast cancer surgery were included in this prospective cohort study. Pre- and postoperative outcomes related to pain, psychosocial, and somatosensory functioning (questionnaires and quantitative sensory testing) were evaluated as risk factors for pain intensity (visual analog scale) and pain-related disability (pain disability index) 1 year after surgery for breast cancer. Both bivariable and stepwise linear regression analyses were performed. RESULTS: The most consistent biopsychosocial risk factors were symptoms related to altered central somatosensory functioning (central sensitization inventory), psychological symptoms, and social support (psychological symptoms and support subscale of McGill Quality of Life Questionnaire). Results also showed that a pre- and postoperative disturbed functioning of the somatosensory nervous system in the surgical area could provide additional information regarding pain intensity or pain-related disability in the long term after surgery for breast cancer. CONCLUSION: This study revealed several biopsychosocial characteristics that might be used to identify women more vulnerable to have pain and pain-related disability in the long term after surgery for breast cancer, allowing for more effective pain management and prevention.

Is evaluation by questionnaires sufficient to cover all aspects of bowel symptoms in rectal cancer patients after low anterior resection?

AIM: The aim of the study was to investigate whether bowel symptoms related to low anterior resection for rectal cancer can be sufficiently well evaluated by the Low Anterior Resection Syndrome (LARS) questionnaire score or the ColoRectal Functional Outcome (COREFO) questionnaire compared with a stool diary. METHOD: All patients underwent low anterior resection for rectal cancer. They were asked to fill out a stool diary, the LARS questionnaire and the COREFO questionnaire, at 1, 4, 6 and 12 months after low anterior resection or stoma closure. The main outcome measure was the amount of association (calculated by means of canonical correlation analysis) between items on anal incontinence for faeces, frequency of bowel movements, clustering of bowel movements, urgency and soiling. RESULTS: Ninety-five patients were included. Items on anal incontinence for faeces and frequency of bowel movements were significantly correlated between the LARS questionnaire or the COREFO questionnaire, versus the stool diary, respectively. Items on soiling were significantly correlated between the COREFO questionnaire and the stool diary. CONCLUSION: Although the LARS questionnaire and the COREFO questionnaire are reliable and valid for measuring low anterior resection syndrome after rectal cancer, our results show that there are no strong associations with the stool diary. Therefore, we can conclude that there is additional clinical information to be obtained from the stool diary. In order to evaluate all aspects of low anterior resection syndrome, we suggest the addition of a stool diary or a combination of different measurement methods during patient follow-up.

Physical Activity Levels of Breast Cancer Patients Before Diagnosis Compared to a Reference Population: A Cross-Sectional Comparative Study.

PURPOSE: We hypothesize that prediagnosis physical activity (PA) levels of breast cancer patients are below those of a reference population without breast cancer. Therefore, the aim of the present study was to compare prediagnosis PA levels (including total-, occupational-, sport- and household activity levels) of breast cancer patients with activity levels of a reference population. METHODS: Female patients with primary breast cancer (n = 265) filled in the Flemish Physical Activity Computerized Questionnaire (FPACQ) the day before surgery recalling the year before diagnosis. PA levels were expressed as Metabolic Equivalent Task (MET) values. Smooth reference curves of PA levels were estimated in a representative sample of 3466 women without breast cancer with the LMS method, which allowed comparison of prediagnosis PA data of the breast cancer sample with this reference. RESULTS: Compared to women without breast cancer, total PA levels were significantly lower in the year prior to breast cancer diagnosis over all age groups (Mean ± SD z-scores (95% CI) = -1.51 ± 1.86 (-1.74 to -1.29)). More specifically, household PA levels of breast cancer patients were significantly lower between ages 40-60, while occupational PA levels were significantly higher in this age group. No differences were found between sports PA levels. CONCLUSIONS: Patients with breast cancer show significantly lower total PA levels during the year prior to surgery compared to a reference population. Especially household activity levels are lower in patients between ages 40 and 60. Given this, a return to prediagnosis PA levels may not be sufficient for protection from disease in the future.

Cognitions and physical impairments in relation to upper limb function in women with pain and myofascial dysfunctions in the late stage after breast cancer surgery: an exploratory cross-sectional study.

PURPOSE: Upper limb (UL) function is one of the health outcomes that matters the most for women with breast cancer. However, a better understanding of the factors contributing to UL dysfunctions in the late stage after breast cancer surgery is needed. This study explores associations between impairment-related and cognition-related factors and UL function in women with pain and myofascial dysfunctions at the affected UL region in this late stage after breast cancer surgery. METHODS: In forty-one women, UL function (dependent variable) was evaluated by the Disabilities of Arm, Shoulder and Hand questionnaire. As independent impairment-related factors, relative excessive arm volume (perimetry), pain intensity (maximum score on the visual analogue scale past week) and humerothoracic elevation and scapular lateral rotation (kinematic analysis) were assessed. As independent cognition-related factors, pain catastrophizing (Pain Catastrophizing Scale) and pain hypervigilance (Pain Vigilance and Awareness Questionnaire) were evaluated. Bi-variable analyses and a stepwise regression analysis were used to explore associations. RESULTS: A higher pain intensity (r = 0.52; p < 0.001), more pain catastrophizing (r = 0.49; p < 0.001) and more pain hypervigilance (r = 0.40; p = 0.01) were related to more UL dysfunction. Pain intensity (p = 0.029) and pain catastrophizing (p = 0.027) explained furthermore 29.9% of variance in UL function. CONCLUSIONS: Pain intensity and cognition-related factors are significantly associated with UL function in women with pain and myofascial dysfunctions, indicating the need of assessing pain beliefs in women in the late stage after breast cancer surgery.IMPLICATIONS FOR REHABILITATIONPain intensity and pain-related beliefs, including pain attention and catastrophizing, are related to the severity of upper limb dysfunctions in the late stage after breast cancer surgery.Impairments such as lymphedema and movement restrictions seem not related to upper limb function in the assessed sample.To understand upper limb dysfunctions in the late stage after breast cancer, assessing pain beliefs is needed.

Psychometric Validation of the Chinese Version of the Lymphedema Functioning, Disability, and Health Questionnaire for Upper Limb Lymphedema in Patients With Breast Cancer-Related Lymphedema.

BACKGROUND: Breast cancer-related lymphedema (BCRL) has a notable impact on patients' quality of life. However, no instrument is available to assess the problems in functioning due to BCRL in China. OBJECTIVE: The aims of this study were to translate and validate a Chinese version of the Lymphedema Functioning, Disability, and Health Questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL). METHODS: A process of translation and cultural adaptation was conducted based on international standards. The study included 155 patients with BCRL and 90 patients without lymphedema. Psychometric properties that were tested consisted of internal consistency, test-rest reliability, content, construct and discriminant validity. RESULTS: The Cronbach's α was .92, and intraclass correlation coefficient was 0.83. Content validity was confirmed by a sufficient content validity index in item level and scale level. Exploratory factor analysis identified 5 factors accounting for 62.44% of the total variance, and confirmatory factor analysis fit indices were acceptable. Convergent validity was supported by a moderate correlation with the 36-item Short-Form Health Survey Questionnaire and relatively weak correlations with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. There was good divergent validity with all hypotheses evaluating divergent validity were confirmed. Significant differences were found between the lymphedema and nonlymphedema groups. CONCLUSION: The Chinese version of the Lymph-ICF-UL is a valid and reliable instrument that can be used in both clinical and scientific settings in China. IMPLICATIONS: The Chinese version of the Lymph-ICF-UL could be applicable in assessing the impairments in function, activity limitations, and participation restrictions of Chinese patients with BCRL.