Exploring predictors of dysphagia in survivors of head and neck cancer: A cross-sectional study.

PURPOSE: To evaluate the prevalence of dysphagia in survivors of head and neck cancer (sHNC) and to identify the predictors contributing to the development of dysphagia. METHODS: We enrolled 62 sHNC in a cross-sectional study to check the prevalence of dysphagia in sHNC and to evaluate which factors were influencing the presence of this side effect. Besides dysphagia, sociodemographic and clinical characteristics, oral symptoms, maximal mouth opening (MMO), sleep quality and physical condition were evaluated, and a linear regression analysis was performed to verify which of these outcomes impact dysphagia. RESULTS: Among all the sHNC, 85.5% presented dysphagia. The linear regression analysis confirmed that 44.9% of the variance in dysphagia was determined by coughing, MMO and sleep quality, being MMO the most powerful predictor, followed by coughing and sleep quality. CONCLUSION: Dysphagia affected the great majority of sHNC. Moreover, symptoms as coughing, reduced MMO and sleep disorders may act as predictors contributing to the development of dysphagia. Our results emphasize the importance of an early and proper identification of the symptoms as well as an adequate treatment strategy to address the cluster of symptoms that sHNC undergo.

Effect of a Multimodal Supervised Therapeutic Exercise Program on Quality of Life, Pain, and Lumbopelvic Impairments in Women With Endometriosis Unresponsive to Conventional Therapy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effectiveness of "Physio-EndEA", a multimodal nine-week supervised exercise intervention, on quality of life, pain, and lumbopelvic impairments in women with endometriosis unresponsive to conventional therapy. DESIGN: Parallel-group randomized controlled trial. Outcomes were measured at baseline, post-intervention, and at 1 year. SETTING: Two Public University Hospitals. PARTICIPANTS: This trial included 31 women with endometriosis (N=31) randomly allocated to "Physio-EndEA" group (n=16) or control group (n=15). Four participants dropped out of the study for causes unrelated to the intervention. INTERVENTIONS: The "Physio-EndEA" program consisted of a 1-week lumbopelvic stabilization learning phase followed by an 8-week phase of stretching, aerobic, and resistance exercises focused on the lumbopelvic area. It was sequentially instructed and supervised by a trained physiotherapist (with volume and intensity progression) and adapted daily to the potential of each participant. Control group received the usual treatment stipulated by their gynecologist. MAIN OUTCOME MEASURES: The primary outcome was quality of life. Secondary outcomes were pain intensity, pressure pain thresholds, pain-related catastrophic thoughts, abdominal and back strength, lumbopelvic stability, and muscle architecture. RESULTS: Adherence rate was 90.6% and mean (±standard deviation) satisfaction was 9.44±0.73 out of 10. No remarkable health problems were reported during the trial. In comparison with controls, the quality of life was improved post-intervention and at 1 year in the Physio-EndEA group with large effect sizes (d>0.80). This group also evidenced: a reduced intensity of dyspareunia, catastrophic thoughts; an increase in pelvic, lumbar, and distal pressure pain thresholds; increases in abdominal and back strength and lumbopelvic stability; and increased thickness of transversus abdominis (right side) and width of lumbar multifidus (left side). CONCLUSION: A 9-week program of multimodal supervised therapeutic exercise is a feasible and effective intervention to improve QoL in women with endometriosis. This program also offers benefits in terms of pain/sensitization and lumbopelvic impairments.

The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

PURPOSE: We aim to evaluate the effects of myofascial induction therapy (MIT) on the sequelae suffered by the survivors of HNC (sHNC). METHODS: We enrolled 46 sHNC in a randomized controlled trial (RCT), of whom 20 received a MIT protocol and 23 were placed on a waitlist while receiving the recommended treatment for 6 weeks. The MIT protocol included a total of 18 sessions, 3 days a week on alternate days for 6 weeks. Maximal mouth opening, the presence of temporomandibular dysfunction, cervical endurance, active range of motion (AROM), shoulder AROM, handgrip strength, and perceived physical fitness were assessed. RESULTS: Maximal mouth opening, temporomandibular dysfunction, cervical endurance, and AROM, affected shoulder abduction and unaffected shoulder flexion and external rotation significantly improved (p < .05) after an MIT protocol, but only cervical AROM and affected shoulder abduction changes were clinically meaningful. No statistically significant changes were observed in the other shoulder AROM, handgrip strength, or physical fitness perception (p > .05). CONCLUSION: A 6-week MIT protocol improves mouth opening, TMD, cervical function (endurance and AROM), affected shoulder abduction and unaffected shoulder flexion, and external rotation AROM in the sHNC. However, no changes were observed in most of the shoulder AROM, muscular strength, or perceived physical fitness. Future studies should perform longer follow-up designs, increase the sample size, and include multimodal treatments to address these sequelae in the sHNC.

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.

Acute and cumulative benefits of Photobiomodulation for xerostomia: A systematic review and meta-analysis.

The objective was to explore the effectiveness of photobiomodulation therapy for treating patients who suffer xerostomia and/or hyposalivation due to the most prevalent clinical diagnoses. We searched PubMed, Scopus, Web of Science, CINAHL and Cochrane Library for randomized or clinical controlled trials published until 31 October 2019. Risk of bias assessment and meta-analysis were conducted using the Cochrane tools. A total of 274 records were retrieved, and 11 met the inclusion criteria. Interventions whose parameters ranged between wavelengths of 790-830 nm (infrared), 30-120 mW of power and an energy density below 30 J/cm-2 were associated with improvements in xerostomia/hyposalivation. As for the assessment of methodological quality, 10 of the 11 articles included had a high risk of overall bias. Only 3 articles provided sufficient information to conduct a meta-analysis for quality of life, compared with placebo in patients with burning mouth syndrome, showing a standardized mean difference between groups from baseline of -0.90 (-1.48; -0.32). The present review and meta-analysis suggest that photobiomodulation therapy is an effective, non-invasive and safe approach in patients with xerostomia. However, despite the potential, it is not possible to reach a reliable consensus on the parameters to be used, and future studies should be conducted by standardizing intervention protocols.

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.

Limitations in Activities of Daily Living Among Spanish Women Diagnosed With Endometriosis.

IMPORTANCE: Understanding the impact of endometriosis symptoms on patients' activities of daily living (ADLs) is a priority to establish effective and personalized intervention programs. OBJECTIVE: To explore limitations in ADLs and instrumental ADLs (IADLs) and their association with pelvic pain (PP), chronic fatigue, and pain-catastrophizing thoughts among women with endometriosis. DESIGN: Cross-sectional study. SETTING: Spain. PARTICIPANTS: Two hundred thirty women with endometriosis. Outcomes and Measures: Information regarding performance of ADLs (Barthel Index) and IADLs (Lawton-Brody questionnaire), PP intensity (Numeric Rating Scale), chronic fatigue (Piper Fatigue Scale), and pain-catastrophizing thoughts (Pain Catastrophizing Scale) was gathered. Multivariate regression analyses were created, and mediating effects of fatigue and pain-catastrophizing thoughts on the association between PP and ADL and IADL limitations were assessed. RESULTS: The prevalence of limitations in at least one ADL and one IADL was 22.6% (95% confidence interval [CI] [17.2, 28.1]) and 39.1% (95% CI [32.8, 45.5]), respectively. Limitations in bowel continence, housework, shopping, and meal preparation were reported most frequently. Women reporting severe PP showed higher risk for ADL (odds ratio [OR] = 3.33, 95% CI [1.10, 10.10]) and IADL (OR = 7.99, 95% CI [2.86, 22.34]) limitations. Chronic fatigue and pain-catastrophizing thoughts were also positively related to ADL-IADL limitations, showing a mediating effect on the association between PP and ADL-IADL limitations. CONCLUSIONS AND RELEVANCE: This study reveals the widespread presence of difficulties in ADL-IADL performance among women with endometriosis, with some symptoms underlying these difficulties in occupational performance. This study points to the need for cost-effective occupational therapy interventions for affected women. What This Article Adds: This research shows that the occupational performance of women with endometriosis is frequently impaired; therefore, the effectiveness of occupational therapy interventions should be addressed in the near future.

Expression of IMP3 in a retrospective cohort of melanomas with selective lymph node biopsy.

Insulin-like growth factor-II mRNA-binding protein 3 (IMP-3), which is a member of the insulin-like growth factor mRNA-binding protein family, is expressed at high levels in many types of cancer, where it plays an important role in cell proliferation, as well as in the processes of invasion, migration, and metastasis. Its expression has also been demonstrated in malignant melanoma, but not in other benign skin lesions, which has raised the possibility of using it as a predictive and prognosis marker. Its relationship with sentinel lymph node biopsy, however, has not been explored yet. A retrospective study including 120 histological samples of patients diagnosed with malignant cutaneous melanoma in Granada, between 2012 and 2018, was developed. All patients had had a sentinel lymph node biopsy (SLNB) performed at Hospital Universitario San Cecilio. IMP3 immunostaining was simultaneously carried out in the cutaneous lesion. We observed a significant difference regarding the percentage of cells expressing IMP3 (29.73 ± 3.81 for negative SLNB vs 44.86 ± 5.91 for positive SLNB, P = .020). Our endpoint calculated according to the ROC curve of 35% was significant with P = .007. H (P = .013) and AR (P = .016) indexes, created by the percentage of positive tumor cells and the intensity of the IMP3 expression, were also statistically significant. The most optimal cut-off points to predict the positivity of the SLNB were 35 for the percentage of positive tumor cells and 70 for the H score. We found a significant association between the expression of IMP3 and the regional nodal status defined by the SLNB on malignant melanomas in our series.

The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial.

BACKGROUND: Generation Z is starting to reach college age. They have adopted technology from an early age and have a deep dependence on it; therefore, they have become more drawn to the virtual world. M-learning has experienced huge growth in recent years, both in the medical context and in medical and health sciences education. Ultrasound imaging is an important diagnosis technique in physiotherapy, especially in sports pathology. M-learning systems could be useful tools for improving the comprehension of ultrasound concepts and the acquisition of professional competencies. OBJECTIVE: The purpose of this study was to evaluate the efficacy and use of an interactive platform accessible through mobile devices-Ecofisio-using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies. METHODS: Participants included 110 undergraduate students who were placed into one of two groups of a randomized controlled multicenter study: control group (ie, traditional learning) and experimental group (ie, Ecofisio mobile app). Participants' theoretical knowledge was assessed using a multiple-choice questionnaire (MCQ); students were also assessed by means of the Objective Structured Clinical Examination (OSCE). Moreover, a satisfaction survey was completed by the students. RESULTS: The statistical analyses revealed that Ecofisio was effective in most of the processes evaluated when compared with the traditional learning method: all OSCE stations, P<.001; MCQ, 43 versus 15 students passed in the Ecofisio and control groups, respectively, P<.001. Moreover, the results revealed that the students found the app to be attractive and useful. CONCLUSIONS: The Ecofisio mobile app may be an effective way for physiotherapy students to obtain adequate professional competencies regarding evaluation and diagnosis of sports pathologies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04138511; https://clinicaltrials.gov/ct2/show/NCT04138511.

A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial.

BACKGROUND: Smartphone-based learning, or mobile learning (m-learning), has become a popular learning-and-teaching strategy in educational environments. Blended learning combines strategies such as m-learning with conventional learning to offer continuous training, anytime and anywhere, via innovative learning activities. OBJECTIVE: The main aim of this work was to examine the short-term (ie, 2-week) effects of a blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app-on knowledge, motivation, mood state, and satisfaction among undergraduate students enrolled in a health science first-degree program. METHODS: The study was designed as a two-armed, prospective, single-blind, randomized controlled trial. Subjects who met the inclusion criteria were randomly assigned to either the intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning). For both groups, the educational program involved 13 lessons on basic health science. The iPOT app is a hybrid, multiplatform (ie, iOS and Android) smartphone app with an interactive teacher-student interface. Outcomes were measured via multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence). RESULTS: A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group. No difference was seen between the two groups in terms of theoretical knowledge gain (P=.92). However, the intervention group subjects returned significantly higher scores than the control group subjects for all postintervention assessed items via the motivation questionnaire (all P<.001). Analysis of covariance (ANCOVA) revealed a significant difference in the confusion and bewilderment component in favor of the intervention group (P=.01), but only a trend toward significance in anger and hostility as well as total score. The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001). Finally, the intervention group subjects who were frequent users of the app showed stronger motivation, as well as increased perception of greater gains in their English-language competence, than did infrequent users. CONCLUSIONS: The blended learning method led to significant improvements in motivation, mood state, and satisfaction compared to traditional teaching, and elicited statements of subjective improvement in terms of competence in English. TRIAL REGISTRATION: ClinicalTrials.gov NCT03335397; https://clinicaltrials.gov/ct2/show/NCT03335397.

Effects of a Single Myofascial Induction Session on Neural Mechanosensitivity in Breast Cancer Survivors: A Secondary Analysis of a Crossover Study.

OBJECTIVES: The purpose of this study was to investigate the short-term effects of myofascial induction on mechanosensitivity of upper limb nerves. METHODS: In this secondary analysis of a randomized, single-blind, placebo-controlled crossover study, 21 breast cancer survivors with stage I-IIIA cancer were randomly allocated to an experimental group (30 minutes of myofascial induction session) or placebo control group (unplugged pulsed 30 minutes of shortwave therapy), with a 4-week washout period between sessions that occurred in a physical therapy laboratory in the Health Science Faculty (University of Granada, Spain). Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry) were assessed during neurodynamic tests and attitude toward massage scale as covariate. RESULTS: An analysis of covariance revealed significant time × group interactions for range of motion in affected upper limb nerves (median, P < .001; radial, P = .036; ulnar, P = .002), but not for nonaffected upper limb nerves (median, P = .083; radial, P = .072; ulnar, P = .796). A χ2 or Fisher exact test, as appropriate, also revealed a significant difference (P = .044) in sensitivity for the affected upper limb ulnar nerve in the experimental group, whereas the rest of the assessed nerves (affected and nonaffected upper limb nerves) showed no significant changes in either the experimental or control groups (P > .05). An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves. CONCLUSION: A single myofascial induction session may partially improve mechanosensitivity of median, radial, and ulnar nerves and yield positive effects on symptom mechanosensitivity, especially regarding the ulnar nerve in breast cancer survivors.

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.

Association Between the Use of a Mobile Health Strategy App and Biological Changes in Breast Cancer Survivors: Prospective Pre-Post Study.

BACKGROUND: There is a bidirectional relationship between chronic low-grade inflammation and cancer. Inflammatory markers, such as interleukin-6 (IL-6), have been associated with both the malignant transformation of epithelial cells and tumor progression, thus linking low-grade inflammation with a higher risk of cancer and recurrence in the survival phase. Therefore, they are considered valuable prognostic biomarkers. Knowing and finding appropriate primary prevention strategies to modify these parameters is a major challenge in reducing the risk of cancer recurrence and increasing survival. Different therapeutic strategies have shown efficacy in the modification of these and other biological parameters, but with contradictory results. There are apparently no strategies in which telemedicine, and specifically mobile health (mHealth), are used as a means to potentially cause biological changes. OBJECTIVE: The objectives of this study were to: (1) check whether it is feasible to find changes in inflammation biomarkers through an mHealth strategy app as a delivery mechanism of an intervention to monitor energy balance; and (2) discover potential predictors of change of these markers in breast cancer survivors (BCSs). METHODS: A prospective quasi-experimental pre-post study was conducted through an mHealth energy balance monitoring app with 73 BCSs, defined as stage I-IIIA of breast cancer and at least six months from the completion of the adjuvant therapy. Measurements included were biological salivary markers (IL-6 and C-reactive protein [CRP]), self-completed questionnaires (the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, the user version of the Mobile Application Rating Scale [uMARS] and an ad hoc clinical and sociodemographic questionnaire) and physical objective measures (accelerometry, weight and height). In addition, using the logging data of the mHealth app, the rate of use (in days) was recorded during the entire experimental phase of the study. Using Stata software, a paired two-tailed t test, Pearson and Spearman correlations, and a stepwise multiple regression analysis were used to interpret the data. RESULTS: Analyzing changes in inflammatory biomarker concentrations after using the mHealth app, differences between preassessment CRP (4899.04 pg/ml; SD 1085.25) and IL-6 (87.15 pg/ml; SD 33.59) and postassessment CRP (4221.24 pg/ml; SD 911.55) and IL-6 (60.53 pg/ml; SD 36.31) showed a significant decrease in both markers, with a mean difference of -635.25 pg/ml (95% CI -935.65 to -334.85; P<.001) in CRP and -26.61 pg/ml (95% CI -42.51 to -10.71; P=.002) in IL-6. Stepwise regression analyses revealed that changes in global quality of life, as well as uMARS score and hormonal therapy, were possible predictors of change in CRP concentration after using the mHealth app. In the same way, the type of tumor removal surgery conducted, as well as changes in weight and pain score, were possible predictors of change in IL-6 concentration after using the app. CONCLUSIONS: In conclusion, through the results of this study, we hypothesize that there is a possible association between an mHealth energy balance monitoring strategy and biological changes in BCSs. These changes could be explained by different biopsychosocial parameters, such as the use of the application itself, quality of life, pain, type of tumor removal surgery, hormonal treatment or obesity.

Health status among long-term breast cancer survivors suffering from higher levels of fatigue: a cross-sectional study.

PURPOSE: The aims of this study were to evaluate the health status of long-term breast cancer survivors (LTBCS) suffering from higher levels of fatigue, to highlight their needs, and to establish the key points of intervention support programs. METHODS: A cross-sectional observational study was conducted at the Sport and Health Joint University Institute (iMUDS) between September 2016 and July 2017 with 80 LTBCS that were classified into non-fatigued (≤ 3.9) or fatigued (≥ 4) according to the Piper Fatigue Scale (PFS) total score. The instruments used were the European Organization for Research and Treatment of Cancer Core 30 and its breast cancer (BC) module, the Visual Analog Scale (VAS), the Brief Pain Inventory (BPI), the Scale for Mood Assessment (EVEA), the International Fitness Scale (IFIS), and the Charlson Comorbidity Index. RESULTS: The analysis revealed that 41.2% of LTBCS were considered moderately fatigued and showed significantly higher levels for the categories of "nausea and vomiting" (P = .005), "pain," "dyspnea" and "insomnia" (P < .001), "appetite loss" (P = .002), "financial difficulties" (P = .010), "systemic therapy side effects" (P < .001), "breast symptoms" and "arm symptoms" (P = .002), and "upset by hair loss" (P = .016). In addition, LTBCS presented significantly higher levels of pain in the affected and non-affected arm, "sadness-depression." "anxiety," "anger/hostility" (All: P < .001), and lower general physical fitness (P < .001). The rest of the variables did not show significant differences. CONCLUSION: LTBCS suffering from higher levels of fatigue had lower QoL, higher level of pain, worse mood state, and lower physical fitness.

Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial.

PURPOSE: This trial determines the effect of an Internet-based tailored exercise program compared to usual care control for improving functional capacity and cognition among breast cancer survivors. METHODS: A two-arm, assessor-blinded, parallel, randomized controlled efficacy trial was conducted. Participants were recruited from the Oncology and Breast unit at the Virgen de las Nieves Hospital (Granada, Spain) between March 2012 to November 2013 and randomized to either the experimental group (an 8-week Internet-based tailored exercise program) or control group (usual care). The outcome measures were the 6-min walk test, Auditory Consonant Trigrams, and Trail Making Test. All were assessed at baseline, post-intervention, and 6-month follow-up. RESULTS: After intervention, the telerehabilitation group had significantly improved distances (d = 0.92, P < 0.001) as well as percentage of predicted of the 6-min walk test (d = 0.93, P < 0.001) compared with the control group. Significant improvement was also observed favoring the telerehabilitation group for the number of consonants recalled in total compared with the control group (d = 0.47, P = 0.04). These findings were maintained after 6-month follow-up (d = 0.80, P = 0.001; d = 0.76, P = 0.002; and d = 0.57, P = 0.02, respectively). Analysis was based on intention-to-treat principle. CONCLUSIONS: These findings support the effectiveness of a telehealth system based on an 8-week physical exercise to achieve improvements and maintain them after 6-month follow-up in terms of functional and cognitive performance in breast cancer survivors. This broad-reach modality could help the growing number of cancer survivors to face their disabling side effects.

Changes in Pain and Muscle Architecture in Colon Cancer Survivors After a Lumbopelvic Exercise Program: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To investigate the efficacy of an eight-week lumbopelvic stabilization program (CO-CUIDATE) for colon cancer survivors. DESIGN: A secondary analysis of a randomized controlled clinical trial. SETTINGS: A blinded, trained researcher performed the end point assessments for pain (Pressure Pain Threshold and Brief Pain Inventory) and muscle architecture (ultrasound imaging measurements). SUBJECTS: Forty-six colon cancer survivors who were assigned to the CO-CUIDATE group or usual care group. METHODS: The CO-CUIDATE program was conducted for eight weeks. A trained researcher who was blinded to patient group performed the assessments. The tests were carried out with multiple observations. Intention-to-treat analyses were performed. RESULTS: The program had an adherence rate of 88.36% and two dropouts (10.5%). The participants reported some minor side effects during the first exercise sessions. The analysis revealed significant differences in the group x time interactions for the lumbar side (dominant: F = 3.1, P < 0.001; nondominant: F = 3.0, P = 0.01) and the infra-umbilical dominant side (F = 1.2, P = 0.04) after the program and at the six-month follow-up and for the internal oblique thickness (F = 5.1, P = 0.030) after the program. The experimental group experienced a greater improvement in all values after the program compared with the control group. There were no significant changes in the other pressure pain threshold points, pain severity, interference of pain, or the remaining ultrasound imaging measurements. CONCLUSION: The CO-CUIDATE program is effective for improving the musculoskeletal conditions related to the lumbopelvic area in colon cancer survivors, specifically in relation to pain and the internal oblique thickness.

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial.

BACKGROUND: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. METHODS: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. DISCUSSION: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).

PaiNEd app. Assessing central sensitization in survivors of breast cancer: A reliability study.

Introduction: Pain is a common adverse event in survivors of breast cancer (sBCs). As there is no gold standard to assess pain experience predominantly related to central sensitization (CS) symptoms, we designed the PaiNEd app, which includes an algorithm to report whether patients are under predominant CS pain mechanisms. Objective: We aimed to assess the reliability of the PaiNEd app to estimate whether sBC pain experience is predominantly related to CS symptoms. Methods: An observational, descriptive reliability design was employed to assess the inter- and intrarater reliability of the PaiNEd app. This app includes an algorithm that considers the number of painful body parts and some questionnaires related to pain, such as the Numeric Pain-Rating Scale, the Brief Pain Inventory, the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Central Sensitization Inventory (CSI). Results: A total of 21 sBCs with persistent pain were recruited. We observe a general trend of close agreement between the paper-based and app-based formats (ICCs ranged between 0.802 and 0.972; Cronbach's alpha ranged between 0.797 and 0.971). Test-retest reliabilities were moderate to excellent (ICCs ranged between 0.510 and 0.941; Cronbach's alpha ranged between 0.499 and 0.938). The agreement between the categorization of the CS algorithm and the CSI (cut-off point ≥ 40 for CS symptoms) was 95.24%. Conclusion: The PaiNEd app emerges as a robust tool for evaluating pain experience predominantly related to CS and pain-related symptoms in sBCs. Its demonstrated reliability not only bolsters its utility but also signifies its potential as a valuable asset for healthcare professionals engaged in pain education programs.

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.

Effect of mHealth plus occupational therapy on cognitive function, mood and physical function in people after cancer: Secondary analysis of a randomized controlled trial.

BACKGROUND: Medical and surgical treatments for breast cancer have various adverse effects. Both mobile health and supervised intervention strategies have been implemented to overcome these effects, but some gaps remain to be addressed. Scientific evidence for the effectiveness of occupational therapy in cancer is limited. OBJECTIVE: To compare the clinical effectiveness of the BENECA mHealth app used alone or combined with an integral supervised rehabilitation strategy that focused on cognitive performance, mood state, functional capacity, and cancer-related pain and fatigue in overweight women after breast cancer. METHODS: In this secondary analysis of an assessor-blinded randomized controlled clinical trial, 80 overweight women after breast cancer (stage I-IIIA) were randomly allocated to an integral approach group (IA; n=40) or a control group (CG; n=40). All participants participated in an 8-week intervention. Assessments were performed at baseline, 8 weeks, and 6 months and included cognitive performance (Trial Making Test and Wechsler Adult Intelligence Scale), psychological state (Hospital Anxiety and Depression Scale), pain (Brief Pain Inventory), fatigue (Piper Fatigue Scale), and physical function (6 min walk test). An intention-to-treat analysis was conducted with analysis of covariance. RESULTS: Selective attention (TMT) was significantly higher in the IA group, with a moderate to large effect size for TMT A (T2: d=1.1; T 3: d=1.2), working memory and processing speed (WAIS), anxiety and general HADS score (d=1.6), and functional capacity at 8 weeks and 6 months (d=1.5). Fatigue perception (mean difference, -0.6; 95% CI -1.4 to 0.04; p=0.009) and pain (intensity level p<0.001; interference level p=0.002) were also significantly more improved in the IA group. CONCLUSIONS: An integral strategy involving the BENECA mHealth app with a supervised, multimodal intervention improved cognitive, psychological, and functional performance in women after breast cancer more than mHealth alone. Occupational therapy has a role to play in breast cancer rehabilitation.