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Giné March, Anna
Promoción de la salud / Educación sanitaria, Práctica clínica basada en la evidencia.
  • Unidad de Investigación en Atención Primaria de Bizkaia
Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.
Artículo
06/02/15
Área:
Promoción de la salud / Educación sanitaria
Ámbito:
Atención Primaria/Comunitaria
Metodología:
Experimental
Población:
Adultos > 18 años
Autores:
Sancho A, Carrera S, Arietaleanizbeascoa M, Arce V, Gallastegui N, Giné March A, Sanz-Guinea A, Eskisabel A, Rodriguez A, Martín RA, Lopez-Vivanco G, Grandes G

Background: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. Design/Methods: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. Discussion: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals.Trial registrationClinicalTrials.gov Identifier: NCT01786122

Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study.
Artículo
30/12/14
Área:
Práctica clínica basada en la evidencia
Ámbito:
Atención Primaria/Comunitaria
Metodología:
Experimental
Población:
Adultos > 18 años
Autores:
San Sebastian KM, Lobato I, Hernández I, Burgos-Alonso N, Gomez-Fernandez M, López J, Rodríguez B, Giné March A, Grandes G, Andia I

Background: Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6). Design: We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP injected subcutaneously into the perilesional tissue and applied topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week. Discussion: The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.Trial registrationCurrent Controlled Trials NCT02213952.