Physiotherapy Interventions in Lung Cancer Patients: A Systematic Review.

BACKGROUND: Lung cancer is a very common disease and leads to a series of sequelae such as reduced lung capacity or reduced functional capacity in patients, which are associated not only with the disease itself, but also with medical treatment. Thus, physiotherapeutic interventions are needed to improve quality of life and reduce these symptoms. OBJECTIVES: To find out the effects of physiotherapy on functional capacity, lung capacity, dyspnea, pain, and quality of life in lung cancer patients. METHODS: A systematic review was carried out in five databases. Randomized clinical trials published between 2019-2023 were selected, in which the physiotherapeutic treatment was physical exercise and/or respiratory physiotherapy. RESULTS: Nine articles were included, in which the total sample consisted of 635 lung cancer patients. When combined, respiratory physiotherapy and physical exercise improved functional capacity and lung capacity (p < 0.05). Dyspnea also improved, but less significance was shown in the included studies. CONCLUSIONS: Multimodal physiotherapy interventions may offer benefits for some lung cancer patients, but the extent and nature of these benefits may vary depending on the intervention applied. Therefore, it would be of great interest to carry out further scientific research to support this conclusion.

Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study.

INTRODUCTION: The role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm2 vs 3 J/cm2) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group. METHODS AND ANALYSIS: A prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm2 of PBM, 3 J/cm2 of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators. ETHICS AND DISSEMINATION: This study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05106608.

Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol.

INTRODUCTION: Pain is one of the most persistent symptoms after cancer treatment. The central nervous system can erroneously stay in its alarm phase, altering the pain experience of patients who have cancer. Pain neuroscience education (PNE) with multimodal approaches may benefit these patients. OBJECTIVE: This protocol aims to determine the effectiveness of a PNE tool on pain, physical function and quality of life, as a supplement to a multimodal rehabilitation (MR) program in patients who had breast cancer (BC). METHODS: An 8-week double-blinded randomized controlled trial will be conducted, including 72 participants who had BC and who have persistent pain, randomized into three groups: PNE program + MR program, traditional biomedical information + MR program and control group. The PNE program will include educational content that participants will learn through a mobile app and the MR program will include a concurrent exercise program and manual therapy. The primary outcome will be the perceived pain assessed using the Visual Analogue Scale and secondary outcomes are others related to pain, physical function and quality of life. All outcomes will be evaluated at baseline, at the end of the intervention and 6 months after the end of intervention. DISCUSSION: The proposed study may help BC patients with persistent pain improve their pain experience, quality of life and provide for more adaptive pain-coping strategies. This protocol could propose an action guide to implement different integral approaches for the treatment of sequelae. This treatment option could be offered to this patient profile and it could be easily implemented in the healthcare systems due to its low costs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04877860. (February18, 2022).

Nonlinear, Multicomponent Physical Exercise With Heart Rate Variability-Guided Prescription in Women With Breast Cancer During Treatment: Feasibility and Preliminary Results (ATOPE Study).

OBJECTIVE: The purpose of this study was to examine the feasibility, safety, adherence, and preliminary efficacy of the ATOPE program during radiotherapy (RT) or chemotherapy (CT) for women with breast cancer. METHODS: This single-blind, pretest-posttest feasibility study included 38 women with breast cancer at the beginning of their treatment. The ATOPE program consisted of 12 to 18 sessions of a multimodal physical exercise program, prescribed based on daily heart rate variability and clinimetric assessments using the ATOPE+ mHealth system. Overall health was assessed with quality of life, autonomous balance, and body composition, whereas health-related fitness was measured through functional capacity, physical activity levels, and upper and lower limb strength. RESULTS: The rates of recruitment, retention, and adherence were 52.35, 73.68, and 84.37%, respectively, and the satisfaction rating was 9.2 out of a possible 10 points. The perceived health status change score was 3.83 points, scored on a -5 to 5 point scale. No adverse effects were found. Compliance results showed that the ATOPE+ mHealth system was used on 73.38% of the days, and the Fitbit bracelet (Google, Mountain View, CA, USA) was used on 84.91% of the days. Women stayed physically active 55% of days. Regarding preliminary results, for overall health, the percentage of body fat in the RT group decreased by 1.93%, whereas it increased by 5.03% in the CT group. Lower limb strength increased in the RT group, specifically knee extensor isometric strength (6.07%), isokinetic knee flexors 180 degree/second (1.53%), and isokinetic knee extensors 300 degree/second (4.53%), in contrast with the reductions found in the CT group (11.07, 18.67, and 14.89%, respectively). CONCLUSION: The ATOPE program, through nonlinear prescription based on daily monitoring with the ATOPE+ mHealth system, is feasible and safe for application during breast cancer treatment. The results suggest that the overall health can be maintained or even improved regarding most variables. IMPACT: This study focused on the feasibility, safety, and completion of a physical therapist-led program at early diagnosis for adults with breast cancer. The multimodal, supervised, tailored, nonlinear physical exercise program is feasible and safe, showed a good completion rate, and was able to prevent the quality-of-life deficits that are often triggered by systemic breast cancer treatment. This study highlights the importance of daily morning assessments using the ATOPE+ mHealth system in patients with breast cancer to prescribe nonlinear physical exercise.

The minimal clinically important difference in the treadmill six-minute walk test in active women with breast cancer during and after oncological treatments.

PURPOSE: To examine the minimal clinically important difference (MCID) in the treadmill 6-minute walk test (6MWT) in women with breast cancer. MATERIALS AND METHODS: A secondary analysis of cross-sectional data from 112 women who were undergoing chemotherapy or had undergone anticancer treatment was conducted. Participants completed the 6MWT on a treadmill and the European Organization for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30) twice, eight weeks apart. Change in the physical function domain of the EORTC-QLQ-C30 was used to classify the "positive change" subgroup (≥5 points difference) and the "unchanged" subgroup (<5 points difference). This was combined with the distance difference from the 6MWTs, determining the MCID as the cut-off from the area under the receiver operating characteristic (AUROC) curve (anchor-based determination). The MCID was also determined from (1) the effect size and (2) the difference in standard error (SEM) of the results of the first and second 6MWT (distribution-based determination). RESULTS: The MCIDs in the during-chemotherapy group was 66.5 and 41.5 m and those in the after-treatment group to be 41.4 and 40.5 m (SEM and effect size based respectively). CONCLUSIONS: The MCID in the treadmill 6MWT distance could be used to interpret changes in the physical health status of women with breast cancer.IMPLICATIONS FOR REHABILITATIONThe MCID for the 6MWT on treadmill in active women with breast cancer is of approximately 54 m during chemotherapy, and 41.6 m after treatment.The MCID on treadmill 6MWT distance could be used to interpret a decline in the physical health status of women with breast cancer.The 6MWT on treadmill could be an easy, feasible, performed under controlled conditions, alternative to the 6MWT to obtain valuable information in this population.

mHealth system (ATOPE+) to support exercise prescription in breast cancer survivors: a reliability and validity, cross-sectional observational study (ATOPE study).

Physical exercise is known to be beneficial for breast cancer survivors (BCS). However, avoiding nonfunctional overreaching is crucial in this population, as they are in physiological dysregulation. These factors could decrease their exercise capacity or facilitate nonfunctional overreaching, which can increase their risk of additional morbidities and even all-cause mortality. The focus of this study is to evaluate the reliability and validity of the ATOPE+ mHealth system to estimate autonomic balance and specific wellness parameters associated with BCS' perceived load, thereby informing nonlinear prescriptions in individualized physical exercise programs for BCS.Twenty-two BCS were included in the reliability and validity analysis. Measures were taken for four days, including morning autonomic balance by heart rate variability, self-reported perception of recovery from exercise, sleep satisfaction, emotional distress and fatigue after exertion. Measures were taken utilizing the ATOPE+ mHealth system application. The results of these measures were compared with criterion instruments to assess validity.The reliability results indicated that the intraclass correlation coefficient (ICC) showed an excellent correlation for recovery (0.93; 95% CI 0.85-0.96) and distress (0.94, 95% CI 0.89-0.97) as well as good correlation for the natural logarithm of the mean square root differences of the standard deviation (LnRMSSD) (0.87; 95% CI 0.74-0.94). Sleep satisfaction also showed an excellent correlation with a weighted kappa of 0.83. The validity results showed no significant differences, except for fatigue. ATOPE+ is reliable and valid for remotely assessing autonomic balance, perception of recovery, sleep satisfaction and emotional distress in BCS; however, it is not for fatigue. This highlights that ATOPE+ could be an easy and efficient system used to assess readiness in BCS, and could help to improve their health by supporting the prescription of optimal and safe physical exercise. Trial registration NCT03787966 ClinicalTrials.gov, December 2019 [ATOPE project]. https://clinicaltrials.gov/ct2/show/NCT03787966 .

A Telehealth-Based Cognitive-Adaptive Training (e-OTCAT) to Prevent Cancer and Chemotherapy-Related Cognitive Impairment in Women with Breast Cancer: Protocol for a Randomized Controlled Trial.

BACKGROUND: Many women with breast cancer experience a great number of side effects, such as cognitive impairment, during and after chemotherapy that reduces their quality of life. Currently, research focusing on the use of non-pharmacological, and specifically telehealth interventions to prevent or mitigate them has been insufficient. METHODS: This protocol describes a randomized controlled trial aimed at studying the preventive effects of a videoconferenced cognitive-adaptive training (e-OTCAT) program (ClinicalTrials.gov NCT04783402). A number of 98 eligible participants will be randomized to one of the following groups: (a) the experimental group receiving the e-OTCAT program during 12 consecutive weeks since the beginning of chemotherapy; and (b) the control group receiving and educational handbook and usual care. The primary outcome will be the cognitive function. Secondary measures will be psychological distress, fatigue, sleep disturbance, quality of life and occupational performance. The time-points for these measures will be placed at baseline, after 12 weeks and six months of post-randomization. CONCLUSION: This trial may support the inclusion of multidimensional interventions through a telehealth approach in a worldwide growing population suffering from breast cancer, emphasizing the prevention of cognitive impairment as one of the side effects of cancer and its treatments.

Can Physical Exercise Prevent Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer? A Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review analyzed the effects of physical exercise programs in patients with cancer undergoing chemotherapy on chemotherapy-induced peripheral neuropathy (CIPN) prevention. DATA SOURCES: PubMed, Web of Science, Scopus, and Cochrane Library were searched for relevant studies published before December 2020. Additional references were identified by manual screening of the reference lists. STUDY SELECTION: Based on the Population, Intervention, Comparator, Outcomes, and Study Designs strategy, randomized controlled trials in which physical exercise was applied before or during chemotherapy to prevent or ameliorate CIPN were included. DATA EXTRACTION: Two reviewers blinded and independent screened the articles, scored methodologic quality, and extracted data for analysis. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Sensitivity and precision analysis databases was included. Risk of bias assessment and meta-analysis were conducted using the Cochrane tools. DATA SYNTHESIS: Of 229 potentially relevant studies, 8 randomized controlled trials were included and scored. They comprise a total of 618 patients with cancer. MEDLINE and Scopus databases recorded the highest sensitivity. None of the studies achieved a "low" overall risk of bias. Four studies were included in meta-analysis for quality of life, and a significance standardized mean difference was found between groups from baseline of 14.62; 95% CI, 6.03-3.20, with a large effect size g=0.83; 95% CI, 0.48-1.18) in favor of physical exercise program compared with usual care. CONCLUSIONS: Physical exercise at the onset of chemotherapy has shown promising effects on the prevention of CIPN, specially improving quality of life.

Colorectal cancer pain upon diagnosis and after treatment: a cross-sectional comparison with healthy matched controls.

BACKGROUND: The current study sought to explore whether cancer pain (CP) already exists in patients at colorectal cancer (CRC) diagnosis before treatment compared with patients with colorectal cancer (CRC) after treatment and a healthy matched control group. The study also sought to examine whether factors related to physical health status could enhance pain processes. METHODS: An observational cross-sectional study was conducted following the STROBE checklist. Twenty-nine newly diagnosed and forty post-treatment patients with CRC and 40 healthy age/sex-matched controls were included for comparison. Pain, local muscle function, and body composition outcomes were assessed by a physiotherapist with > 3 years of experience. ANCOVA and Kruskal-Wallis tests were performed, with Bonferroni and Dunn-Bonferroni post hoc analyses and Cohen's d and Hedge's effect size, as appropriate. RESULTS: The analysis detected lower values of pressure pain threshold (PPT) points, the PPT index, and abdominal strength and higher values of self-reported abdominal pain in newly diagnosed patients, with even more marked results observed in the post-treatment patients, where lower lean mass and skeletal muscle index values were also found than those in the healthy matched controls (p < 0.05). In the post-treatment and healthy matched control groups, positive associations were observed between the PPT lumbar dominant side points and abdominal isometric strength and lean mass, and negative associations were observed between the lumbar dominant side points and body fat (p < 0.05). CONCLUSION: Upon diagnosis, patients with CRC already show signs of hyperalgesia and central sensitization and deteriorated physical conditions and body composition, and this state could be aggravated by subsequent treatments.

Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol.

OBJECTIVE: This trial will analyze the acute and cumulative effects of a tailored program called PRESIONA that combines therapeutic exercise and blood flow restriction to prevent chemotherapy-induced peripheral neuropathy (CIPN) in individuals with early breast cancer undergoing neoadjuvant chemotherapy. METHODS: PRESIONA will be a physical therapist-led multimodal exercise program that uses blood flow restriction during low-load aerobic and strength exercises. For the acute study, only 1 session will be performed 1 day before the first taxane cycle, in which 72 women will be assessed before intervention and 24 hours post intervention. For the cumulative study, PRESIONA will consist of 24 to 36 sessions for 12 weeks following an undulatory prescription. At least 80 women will be randomized to the experimental group or control group. Feasibility will be quantified based on the participant recruitment to acceptance ratio; dropout, retention, and adherence rates; participant satisfaction; tolerance; and program security. In the efficacy study, the main outcomes will be CIPN symptoms assessed with a participant-reported questionnaire (EORTC QLQ-CIPN20). In addition, to determine the impact on other participant-reported health and sensorimotor and physical outcomes, the proportion of completed scheduled chemotherapy sessions will be examined at baseline (t0), after anthracycline completion (t1), after intervention (t2), and at the 2-month (t3) and 1-year follow-ups (t4). CONCLUSION: The proposed innovative approach of this study could have a far-reaching impact on therapeutic options, and the physical therapist role could be essential in the oncology unit to improve quality of life in individuals with cancer and reduce side effects of cancer and its treatments. IMPACT: Physical therapists in the health care system could be essential to achieve the planned doses of chemotherapy to improve survival and decrease the side effects of individuals with breast cancer. The prevention of CIPN would have an impact on the quality of life in these individuals, and this protocol potentially could provide an action guide that could be implemented in any health care system.

Systematic review of the effect of aquatic therapeutic exercise in breast cancer survivors.

BACKGROUND: Aquatic therapeutic exercise can be equally effective or even superior to land-based exercise in improving several clinical variables. However, there is still a lack of knowledge on the effects compared to land-based interventions particularly in breast cancer (BC) patients. OBJECTIVE: The objective of this study is to examine the effects of aquatic therapeutic exercise on pain, shoulder mobility, lymphedema, cardiorespiratory fitness, muscle strength, body composition, pulmonary function, cancer-related fatigue (CRF) and health-related quality of life (HRQoL) and which parameters are effective compared to similar land-based interventions. METHODS: The databases used were PubMed, Scopus, Web of Science, Cochrane Library and CINAHL, retrieving 145 articles. RESULTS: Eleven studies were included. Aquatic therapeutic exercise is feasible, safe, well tolerated and achieved high percentages of adherence. As for the assessed outcomes, moderate to large improvements were found compared to usual care or to land-based physical exercise interventions in pain, shoulder range of motion, pulmonary function, HRQoL, cardiorespiratory fitness and muscle strength. Inconclusive results were found for lymphedema, body composition and CRF. CONCLUSIONS: Aquatic therapeutic exercise interventions using a combination of endurance, strength, mobility, stretching and breathing exercises resulted in improvements in common side effects of BC and its treatments. More studies on CRF, body composition and lymphedema need to be done to further evaluate the impact of the intervention on these outcomes.

Myofascial Induction Therapy Improves the Sequelae of Medical Treatment in Head and Neck Cancer Survivors: A Single-Blind, Placebo-Controlled, Randomized Cross-Over Study.

Head and neck cancer (HNC) is the sixth most common cancer worldwide. Yet, less than 60% of HNC survivors receive adequate therapy for treatment-related sequelae. The objective of this study was to determine the efficacy of myofascial induction therapy (MIT) in improving cervical and shoulder pain and range of motion, maximal mouth opening, and cervical muscle function in HNC survivors. This crossover, blinded, placebo-controlled study involved 22 HNC survivors (average age 56.55 ± 12.71) of which 13 were males (59.1%) who received, in a crossover fashion, both a single 30-min session of MIT in the form of manual unwinding and simulated pulsed shortwave therapy (placebo), with a 4-week washout interval between the two. Cervical and shoulder pain (visual analogue scale) and range of motion (cervical range of motion device and goniometer), maximum mouth opening (digital caliper), and cervical muscle function (deep cervical flexor endurance test) were measured before and after the treatment and placebo sessions. A single session of MIT improved cervical and affected side shoulder pain, cervical range of motion, maximum mouth opening, and cervical muscle function. The associated effect sizes ranged from moderate to large. The present study suggests that MIT, in the form of manual unwinding, improves cervical (-3.91 ± 2.77) and affected-side shoulder (-3.64 ± 3.1) pain, cervical range of motion (flexion: 8.41 ± 8.26 deg; extension: 12.23 ± 6.55; affected-side rotation: 14.27 ± 11.05; unaffected-side rotation: 11.73 ± 8.65; affected-side lateroflexion: 7.95 ± 5.1; unaffected-side lateroflexion: 9.55 ± 6.6), maximum mouth opening (3.36 ± 3.4 mm), and cervical muscle function (8.09 ± 6.96 s) in HNC survivors.

Neurotoxicity prevention with a multimodal program (ATENTO) prior to cancer treatment versus throughout cancer treatment in women newly diagnosed for breast cancer: Protocol for a randomized clinical trial.

A current challenge in breast cancer (BC) patients is how to reduce the side effects of cancer and cancer treatments and prevent a decrease in quality of life (QoL). Neurotoxic side effects, especially from chemotherapy, are present in up to 75% of women with BC, which implies a large impact on QoL. There is a special interest in the preventive possibilities of therapeutic exercise (TE) for these neurological sequelae, and the benefits of TE could be improved when it is combined with vagal activation techniques (VATs). This superiority randomized controlled trial aims to examine the feasibility and efficacy of an 8-week multimodal intervention (ATENTO) based on moderate-vigorous intensity and individualized TE (aerobic and strength exercises) and VAT (myofascial and breathing exercises), on neurotoxicity prevention in women with BC before starting adjuvant chemotherapy (ATENTO-B) versus throughout adjuvant chemotherapy (ATENTO-T). A sample of 56 women newly diagnosed with BC, as calculated with a power of 85%, will be randomly allocated into these two groups. This study could provide an impetus for the introduction of early multimodal intervention methods to prevent neurotoxicity and consequently avoid the QoL deterioration that BC patients presently suffer throughout their treatments.

Effectiveness of Antalgic Therapies in Patients with Vertebral Bone Metastasis: A Protocol for a Systematic Review and Meta-Analysis.

There is no systematic review that has identified existing studies evaluating the pharmacological and non-pharmacological intervention for pain management in patients with bone metastasis. To fill this gap in the literature, this systematic review with meta-analysis aims to evaluate the effectiveness of different antalgic therapies (pharmacological and non-pharmacological) in the improvement of pain of these patients. To this end, this protocol has been written according to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) and registered in PROSPERO (CRD42020135762). A systematic search will be carried out in four international databases: Medline (Via PubMed), Web of Science, Cochrane Library and SCOPUS, to select the randomized controlled clinical trials. The Risk of Bias Tool developed by Cochrane will be used to assess the risk of bias and the quality of the identified studies. A narrative synthesis will be used to describe and compare the studies, and after the data extraction, random effects model and a subgroup analyses will be performed according to the type of intervention, if possible. This protocol aims to generate a systematic review that compiles and synthesizes the best and most recent evidence on the treatment of pain derived from vertebral metastasis.

Attenuating Treatment-Related Cardiotoxicity in Women Recently Diagnosed With Breast Cancer via a Tailored Therapeutic Exercise Program: Protocol of the ATOPE Trial.

OBJECTIVE: Therapeutic exercise is already used to ameliorate some of the side effects of cancer treatment. Recent studies examined its preventive potential regarding treatment-related toxicity, which can increase the risk of functional decline and lead to disease recurrence and death. This trial will examine whether the Tailored Therapeutic Exercise and Recovery Strategies (ATOPE) program, performed before treatment, can mitigate the onset and extent of cardiotoxicity beyond that achieved when the program is followed during treatment in recently diagnosed breast cancer patients. METHODS: The intervention has a preparatory phase plus 12 to 18 sessions of tailored, high-intensity exercise, and post-exercise recovery strategies. A total of 120 women recently diagnosed with breast cancer, at risk of cardiotoxicity due to anticancer treatment awaiting surgery followed by chemotherapy and/or radiotherapy, will be randomized to either group. In a feasibility study, measurements related to recruitment rate, satisfaction with the program, adherence to them, the retention of participants, safety, and adverse effects will be explored. In the main trial, the efficacy of these interventions will be examined. The major outcome will be cardiotoxicity, assessed echocardiographically via the left ventricular ejection fraction. Other clinical, physical, and anthropometric outcomes and biological and hormonal variables will also be assessed after diagnosis, after treatment, 1 year after treatment ends, and 3 years after treatment ends. CONCLUSION: Given its potential effect on patient survival, the mitigation of cardiotoxicity is a priority, and physical therapists have an important role in this mitigation. If the ATOPE intervention performed before treatment returns better cardioprotection results, it may be recommendable that patients recently diagnosed follow this program. IMPACT: The ATOPE program will highlight the need for a physical therapist intervention from the moment of diagnosis, in the prevention or mitigation of cardiotoxicity, in women with breast cancer. It could help physical therapists to establish an adequate therapeutic exercise dose adapted to breast cancer patients and to propose correct therapeutic exercise prescription according to the assimilation of the sessions.

Patterns of pharmacologic and non-pharmacologic treatment, treatment satisfaction and perceived tolerability in patients with fibromyalgia: a patients' survey.

OBJECTIVES: To evaluate the patterns of treatment among patients with fibromyalgia (FM) in Spain and to assess patient satisfaction and perceived tolerability of the treatment received. METHODS: An observational, cross-sectional study was conducted in Spain via internet from September 2015 to March 2017. We recorded sociodemographic and clinical information, including treatment satisfaction evaluated using a 10-point numerical rating scale (NRS) and adverse events. RESULTS: Evaluable subjects (n=915) were predominantly middle-aged, married women who presented with moderate to severe pain, sleep disturbance and affected quality-of-life. The most frequent non-pharmacologic treatments were physical exercise (85%), diet (47%), supplements such as magnesium and vitamins (47%), and psychotherapy (31%). The most frequently prescribed drugs were tramadol (40%), benzodiazepines (30%), duloxetine (22%), pregabalin (19%), amitriptyline (17%) and nonsteroidal anti-inflammatory drugs (NSAIDs; 16%); 7.5% of patients received stronger opioids. After excluding benzodiazepines, NSAIDs, and paracetamol, 46% of patients received ≥2 drugs. Satisfaction with treatment (NRS mean score) was generally poor for pharmacologic treatment (4.1), exercise (4.7), psychotherapy (5.2), diet (5.0), physiotherapy (6.2) and acupuncture (6.3). The increase in the number of drugs prescribed was not associated with an increase in satisfaction, but rather with an increase in adverse events. CONCLUSIONS: Patients with FM in Spain are overtreated with a combination of non-pharmacologic and pharmacologic therapies. Several of these therapies lack adequate support from randomised clinical trials and/or clinical practice guidelines. This overtreatment is not associated with relevant clinical benefits or patient satisfaction and, in the case of pharmacologic treatments, poses tolerability and safety issues.

A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

BACKGROUND: Breast cancer patients have to face a high-risk state during chemotherapy, which involves deterioration of their health including extensive physical deterioration. Face-to-face physical exercise programs have presented low adherence rates during medical treatment, and telehealth systems could improve these adherence rates. OBJECTIVE: This study aimed to evaluate the effectiveness of a Web-based exercise program (e-CuidateChemo) to mitigate the side effects of chemotherapy on the physical being, anthropometric aspects, and body composition. METHODS: A total of 68 patients diagnosed with breast cancer, who were undergoing chemotherapy, were enrolled. The patients were categorized into two groups: e-CuidateChemo (n=34) and controls (n=34). The e-CuidateChemo group participated in an adapted 8-week tailored exercise program through a Web-based system. A blinded, trained researcher assessed functional capacity, strength, anthropometric parameters, and body composition. The intervention effects were tested using analysis of covariance and Cohen d tests. RESULTS: Functional capacity improved significantly in the e-CuidateChemo group compared to the control group (6-minute walk test: 62.07 [SD 130.09] m versus -26.34 [SD 82.21] m; 6-minute walk test % distance predicted: 10.81% [SD 22.69%] m versus -4.60% [SD 14.58%]; between-group effect: P=.015 for both). The intervention group also showed significantly improved secondary outcomes such as between-group effects for abdominal (24.93 [SD 26.83] s vs -18.59 [SD 38.69] s), back (12.45 [SD 10.20] kg vs 1.39 [10.72] kg), and lower body (-2.82 [SD 3.75] s vs 1.26 [SD 2.84] s) strength; all P<.001 compared to the control group. CONCLUSIONS: This paper showed that a Web-based exercise program was effective in reversing the detriment in functional capacity and strength due to chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02350582; https://clinicaltrials.gov/ct2/show/NCT02350582.

A Mobile System to Improve Quality of Life Via Energy Balance in Breast Cancer Survivors (BENECA mHealth): Prospective Test-Retest Quasiexperimental Feasibility Study.

BACKGROUND: Energy balance is defined as the difference between energy expenditure and energy intake. The current state of knowledge supports the need to better integrate mechanistic approaches through effective studies of energy balance in the cancer population because of an observed significant lack of adherence to healthy lifestyle recommendations. To stimulate changes in breast cancer survivors' lifestyles based on energy balance, our group developed the BENECA (Energy Balance on Cancer) mHealth app. BENECA has been previously validated as a reliable energy balance monitoring system. OBJECTIVE: Based on our previous results, the goal of this study was to investigate the feasibility of BENECA mHealth in an ecological clinical setting with breast cancer survivors, by studying (1) its feasibility and (2) pretest-posttest differences with regard to breast cancer survivor lifestyles, quality of life (QoL), and physical activity (PA) motivation. METHODS: Eighty breast cancer survivors diagnosed with stage I to IIIA and with a body mass index over 25 kg/m2 were enrolled in this prospective test-retest quasi-experimental study. Patients used BENECA mHealth for 8 weeks and were assessed at baseline and the postintervention period. Feasibility main outcomes included percentage of adoption, usage, and attrition; user app quality perception measured with the Mobile App Rating Scale (MARS); satisfaction with the Net Promoter Score (NPS); and barriers and facilitators of its use. Clinical main outcomes included measuring QoL with the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORT QLQ-C30), PA assessment with accelerometry, PA motivation measure with a Spanish self-efficacy scale for physical activity (EAF), and body composition with dual-energy x-ray absorptiometry. Statistical tests (using paired-sample t tests) and Kaplan-Meier survival curves were analyzed. RESULTS: BENECA was considered feasible by the breast cancer survivors in terms of use (76%, 58/76), adoption (69%, 80/116), and satisfaction (positive NPS). The app quality score did not make it one of the best-rated apps (mean 3.71, SD 0.47 points out of 5). BENECA mHealth improved the QoL of participants (global health mean difference [MD] 12.83, 95% CI 8.95-16.71, P<.001), and EAF score (global MD 36.99, 95% CI 25.52-48.46, P<.001), daily moderate-to-vigorous PA (MD 7.38, 95% CI 0.39-14.37, P=.04), and reduced body weight (MD -1.42, 95% CI -1.97 to -0.87, P<.001). CONCLUSIONS: BENECA mHealth can be considered feasible in a real clinical context to promote behavioral changes in the lifestyles of breast cancer survivors, but it needs to be enhanced to improve user satisfaction with use and functionality. This study highlights the importance of the use of mobile apps based on energy balance and how the QoL of breast cancer survivors can be improved via monitoring.