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.
Breast Neoplasms , Chemotherapy-Related Cognitive Impairment , Telemedicine , Breast Neoplasms/psychology , Cognition , Female , Humans , Quality of Life , Randomized Controlled Trials as Topic
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.
Antineoplastic Agents , Breast Neoplasms , Peripheral Nervous System Diseases , Antineoplastic Agents/adverse effects , Breast Neoplasms/drug therapy , Exercise Therapy , Female , Humans , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/prevention & control , Quality of Life , Randomized Controlled Trials as Topic
Introducción La pandemia por COVID-19 ha modificado nuestra actividad asistencial habitual en los últimos meses. Debido al colapso hospitalario se han suspendido consultas, pruebas diagnósticas e intervenciones quirúrgicas, con el objetivo también de reducir la exposición de pacientes al SARS-CoV-2 en el medio hospitalario. Sin embargo, esto ha provocado un retraso en la atención de otros problemas sanitarios. Material y métodos Analizamos y comparamos los datos de la Unidad de Mama en un hospital de segundo nivel, en cuanto a la actividad del Programa de Diagnóstico Precoz de Cáncer de Mama (PDPCM), los diagnósticos de cáncer realizados, así como las pacientes intervenidas durante los meses de marzo a mayo de 2020, con respecto al mismo período del año anterior. Resultados El número de pacientes atendidas en el PDPCM en los meses de marzo a mayo de 2020 se ha reducido en un 91,7%, y las pacientes atendidas en el Servicio de Radiodiagnóstico del hospital en un 54,2%. La actividad quirúrgica también se ha visto mermada en un 57,69% con respecto al mismo periodo del año anterior. Conclusiones La disminución de la actividad del PDPCM y Radiología conllevan a un retraso diagnóstico que concluirá con un aumento de lista de espera y demora en el tratamiento, lo que posiblemente derive en un diagnóstico en estadios más avanzados de la enfermedad. (AU)
Introduction The COVID-19 pandemic has changed routine clinical activity in the last few months. Because our hospital was overwhelmed and to prevent patient exposure to SARS-CoV-2 in the hospital setting, consultations, diagnostic tests, and surgical interventions have been postponed. However, this has provoked a delay in the care of other health problems. Material and methods We analysed and compared the data from the breast unit of a second-level hospital in terms of the activity of the Early Breast Cancer Detection Programme (EBCDP), the cancer diagnoses made, and the patients undergoing surgery from March to May, 2020, compared with the same period in the previous year. Results The number of patients attended in the EBCDP in March and May decreased by 91.7% and those attended in the Radiodiagnostics Service of the hospital fell by 54.2%. Surgical activity also decreased by 57.69% compared with the same period in 2019. Conclusions The decrease in the activity of the EBCDP and Radiology Service have led to a diagnostic delay which will, in turn, increase waiting lists and delay treatment. These factors will possibly lead to tumours being diagnosed in more advanced stages. (AU)
Breast Neoplasms/surgery , Breast Neoplasms/diagnosis , Early Detection of Cancer , Radiology
INTRODUCCIÓN: La pandemia por COVID-19 ha modificado nuestra actividad asistencial habitual en los últimos meses. Debido al colapso hospitalario se han suspendido consultas, pruebas diagnósticas e intervenciones quirúrgicas, con el objetivo también de reducir la exposición de pacientes al SARS-CoV-2 en el medio hospitalario. Sin embargo, esto ha provocado un retraso en la atención de otros problemas sanitarios. MATERIAL Y MÉTODOS: Analizamos y comparamos los datos de la Unidad de Mama en un hospital de segundo nivel, en cuanto a la actividad del Programa de Diagnóstico Precoz de Cáncer de Mama (PDPCM), los diagnósticos de cáncer realizados, así como las pacientes intervenidas durante los meses de marzo a mayo de 2020, con respecto al mismo período del año anterior. RESULTADOS: El número de pacientes atendidas en el PDPCM en los meses de marzo a mayo de 2020 se ha reducido en un 91,7%, y las pacientes atendidas en el Servicio de Radiodiagnóstico del hospital en un 54,2%. La actividad quirúrgica también se ha visto mermada en un 57,69% con respecto al mismo periodo del año anterior. CONCLUSIONES: La disminución de la actividad del PDPCM y Radiología conllevan a un retraso diagnóstico que concluirá con un aumento de lista de espera y demora en el tratamiento, lo que posiblemente derive en un diagnóstico en estadios más avanzados de la enfermedad
INTRODUCTION: The COVID-19 pandemic has changed routine clinical activity in the last few months. Because our hospital was overwhelmed and to prevent patient exposure to SARS-CoV-2 in the hospital setting, consultations, diagnostic tests, and surgical interventions have been postponed. However, this has provoked a delay in the care of other health problems. MATERIAL AND METHODS: We analysed and compared the data from the breast unit of a second-level hospital in terms of the activity of the Early Breast Cancer Detection Programme (EBCDP), the cancer diagnoses made, and the patients undergoing surgery from March to May, 2020, compared with the same period in the previous year. RESULTS: The number of patients attended in the EBCDP in March and May decreased by 91.7% and those attended in the Radiodiagnostics Service of the hospital fell by 54.2%. Surgical activity also decreased by 57.69% compared with the same period in 2019. CONCLUSIONS: The decrease in the activity of the EBCDP and Radiology Service have led to a diagnostic delay which will, in turn, increase waiting lists and delay treatment. These factors will possibly lead to tumours being diagnosed in more advanced stages
Humans , Coronavirus Infections/prevention & control , Breast Neoplasms/epidemiology , Hospital Restructuring/organization & administration , Delivery of Health Care/statistics & numerical data , Coronavirus Infections/epidemiology , Early Detection of Cancer/statistics & numerical data , Mass Screening/statistics & numerical data , Mastectomy/statistics & numerical data , Radiotherapy/statistics & numerical data , Secondary Care/organization & administration
BACKGROUND: Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women. METHODS / DESIGN: This study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters. DISCUSSION: This study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth systems could offer a choice of supportive care to cancer patients during the survivorship phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01801527.
Breast Neoplasms/therapy , Exercise Therapy , Internet , Quality of Life , Research Design , Survivors/psychology , Telemedicine/methods , Therapy, Computer-Assisted , Breast Neoplasms/pathology , Breast Neoplasms/psychology , Clinical Protocols , Exercise Test , Feasibility Studies , Female , Humans , Neoplasm Staging , Pain Measurement , Physical Examination , Physical Fitness , Predictive Value of Tests , Risk Reduction Behavior , Spain , Surveys and Questionnaires , Time Factors , Treatment Outcome
