ABSTRACT
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.
Subject(s)
Breast Neoplasms , Chemotherapy-Related Cognitive Impairment , Telemedicine , Breast Neoplasms/psychology , Cognition , Female , Humans , Quality of Life , Randomized Controlled Trials as TopicABSTRACT
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).
Subject(s)
Breast Neoplasms/rehabilitation , Occupational Therapy/methods , Survivors , Telemedicine/methods , Adult , Aged , Female , Humans , Middle AgedABSTRACT
This study examined the relationship between the 6-min walk test (6MWT) and fitness, psychological and physiologic states, quality of life, cancer-related symptoms, and body composition of 87 women with breast cancer. The assessment included the 6MWT and evaluations of Cancer Quality of Life (EORTC C-30 and EORTC BR-23), cognitive performance (Trail Making Test), the Hospital Anxiety and Depression Scale, body composition, health-related fitness (abdominal test, multiple sit-to-stand test, trunk dynamometry), and pain (Brief Pain Inventory). We observed the following correlations: moderate between 6MWT and pain interference; modest for cognitive and social functioning and the multiple sit-to-stand test; fair for several items on the Cancer Quality of Life, for anxiety, lean body mass, trunk dynamometry and pain intensity; and weak for role functioning, loss of appetite, cognitive performance and depression. Thus, the 6MWT could be used as a measure of the major components of global health in women with breast cancer.
Subject(s)
Breast Neoplasms/physiopathology , Breast Neoplasms/psychology , Walk Test , Adolescent , Adult , Aged , Anxiety/psychology , Appetite/physiology , Body Composition , Breast Neoplasms/pathology , Cognition , Cross-Sectional Studies , Depression/psychology , Female , Humans , Middle Aged , Neoplasm Staging , Pain Measurement , Physical Fitness/psychology , Quality of LifeABSTRACT
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.
Subject(s)
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 OutcomeABSTRACT
OBJECTIVE: The purpose of this study was to evaluate the influence of patient's attitudes toward massage on pressure pain sensitivity and the immune effects of myofascial release in breast cancer survivors (BCS). METHODS: Twenty BCS participated. They presented to the laboratory at the same time of the day on 2 occasions separated by 2 weeks. At each session, they received either a myofascial release technique or control (special attention) intervention. Salivary flow rate, cortisol and immunoglobulin A (IgA) concentrations, and α-amylase activity were obtained before and immediately after intervention from saliva samples. Pressure pain thresholds (PPT) over the cervical spine and temporalis muscle were assessed bilaterally. The attitude toward massage (ATOM) scale was collected before the first session in all BCS. RESULTS: The analysis of covariance revealed a significant intervention × time interaction for salivary flow rate (P = .010), but not α-amylase (P = .111), IgA (P = .655), and cortisol (P = .363) in favor of the experimental group: BCS exhibited an increase of salivary flow rate after myofascial release intervention. When the ATOM scale was included in the analysis, significant influence on IgA (P = .001) was found: BCS with positive attitude had a significant increase in IgA (P > .05). The analysis of covariance did not find a significant intervention × time interaction for PPT over the cervical spine or temporalis muscle, with no effect of ATOM scales for PPT (P > .05). CONCLUSION: The current study suggests that myofascial release may lead to an immediate increase in salivary flow rate in BCS with cancer-related fatigue. We also found that the effect of myofascial release on immune function was modulated by a positive patient's attitude toward massage.
Subject(s)
Attitude to Health , Breast Neoplasms/immunology , Massage/methods , Musculoskeletal Pain/therapy , Trigger Points/physiopathology , Adult , Aged , Analysis of Variance , Breast Neoplasms/complications , Breast Neoplasms/diagnosis , Breast Neoplasms/therapy , Cross-Over Studies , Female , Follow-Up Studies , Humans , Immune System/physiology , Middle Aged , Musculoskeletal Pain/etiology , Musculoskeletal Pain/physiopathology , Pain Threshold , Patient Compliance/statistics & numerical data , Patient Satisfaction , Reference Values , Risk Assessment , Survivors , Temporal Muscle/physiopathology , Treatment OutcomeABSTRACT
El uso del reservorio subcutáneo se ha extendido en los últimos años como respuesta a la necesidad de tratamientos crónicos intravenosos. Determinados pacientes como los oncológicos necesitan disponer de un acceso venoso mantenido. En ellos no es aconsejable el uso de una vía venosa periférica por el efecto esclerosante y/o irritante que sobre el endotelio vascular tienen muchas de los fármacos administradas, y por las numerosas punciones venosas a las que a menudo son sometidos. En este sentido, la implantación de un reservorio subcutáneo permanente a nivel central permite obtener muestras de sangre, así como administrar toda clase de tratamientos intravenosos. Si bien, además de ello, aporta la ventaja de una baja incidencia de infecciones, la posibilidad de su uso extrahospitalario y una buena aceptación por parte de los pacientes. El sistema consiste en un catéter venoso siliconado que se sitúa por debajo del tejido celular subcutáneo y proporciona un acceso vascular, fácil de encontrar, seguro y duradero. A pesar de su frecuente uso en la actualidad, dicha técnica no se encuentra totalmente exenta de riesgos, y entre las posibles complicaciones destacan las infecciosas, trombóticas, la migración del catéter, la oclusión, el neumotórax o erosiones vasculares. El objetivo de este trabajo ha sido describir el protocolo de utilización del reservorio subcutáneo llevado a cabo en la unidad de ginecología oncológica del Hospital Universitario Virgen de las Nieves de Granada (AU)
Abstract Use of subcutaneous reservoir has been extended in recent years in response to the need of chronic intravenous treatments. Some cancer patients and need to have a venous access maintained. In them is not advisable to use a peripheral vein, the sclerosing effect and/or irritating on the endothelium have many of the drugs administered, and the numerous venous punctures to which are often subjected. In this regard, the establishment of a permanent subcutaneous reservoir at the central level can obtain blood samples and administer all types of intravenous therapies. Although it also has the advantage of a low incidence of infections, the possibility of outpatient use and well accepted by patients. The system consists of a silicone venous catheter that is placed below the subcutaneous tissue and provides a vascular access, easy to find, secure and durable. Despite its frequent use today, this technique is not completely without risk, and among the possible complications of infectious diseases, thrombosis, catheter migration, occlusion, pneumothorax or vascular erosion. The aim of this study was to describe the protocol using the subcutaneous reservoir held in the unit of gynecologic oncology, University Hospital Virgen de las Nieves in Granada(AU)
Subject(s)
Humans , Male , Genital Neoplasms, Female/drug therapy , Catheterization, Central Venous , Clinical ProtocolsABSTRACT
Use of subcutaneous reservoir has been extended in recent years in response to the need of chronic intravenous treatments. Some cancer patients and need to have a venous access maintained. In them is not advisable to use a peripheral vein, the sclerosing effect and/or irritating on the endothelium have many of the drugs administered, and the numerous venous punctures to which are often subjected. In this regard, the establishment of a permanent subcutaneous reservoir at the central level can obtain blood samples and administer all types of intravenous therapies. Although it also has the advantage of a low incidence of infections, the possibility of outpatient use and well accepted by patients. The system consists of a silicone venous catheter that is placed below the subcutaneous tissue and provides a vascular access, easy to find, secure and durable. Despite its frequent use today, this technique is not completely without risk, and among the possible complications of infectious diseases, thrombosis, catheter migration, occlusion, pneumothorax or vascular erosion. The aim of this study was to describe the protocol using the subcutaneous reservoir held in the unit of gynecologic oncology, University Hospital Virgen de las Nieves in Granada.
