ABSTRACT
BACKGROUND: Patients with hematological malignancies receiving hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T-cell therapy are at risk of developing serious clinical complications after discharge. OBJECTIVE: The aim of the TEL-HEMATO study was to improve our telehealth platform for the follow-up of patients undergoing HCT or CAR T-cell therapy during the first 3 months after discharge with the addition of wearable devices. METHODS: Eleven patients who received autologous (n=2) or allogeneic (n=5) HCT or CAR T-cell therapy (n=4) for hematological malignancies were screened from November 2022 to July 2023. Two patients discontinued the study after enrollment. The telehealth platform consisted of the daily collection of vital signs, physical symptoms, and quality of life assessment up to 3 months after hospital discharge. Each patient received a clinically validated smartwatch (ScanWatch) and a digital thermometer, and a dedicated smartphone app was used to collect these data. Daily revision of the data was performed through a web-based platform by a hematologist or a nurse specialized in HCT and CAR T-cell therapy. RESULTS: Vital signs measured through ScanWatch were successfully collected with medium/high adherence: heart rate was recorded in 8/9 (89%) patients, oxygen saturation and daily steps were recorded in 9/9 (100%) patients, and sleeping hours were recorded in 7/9 (78%) patients. However, temperature recorded manually by the patients was associated with lower compliance, which was recorded in 5/9 (55%) patients. Overall, 5/9 (55%) patients reported clinical symptoms in the app. Quality of life assessment was completed by 8/9 (89%) patients at study enrollment, which decreased to 3/9 (33%) at the end of the third month. Usability was considered acceptable through ratings provided on the System Usability Scale. However, technological issues were reported by the patients. CONCLUSIONS: While the addition of wearable devices to a telehealth clinical platform could have potentially synergic benefits for HCT and CAR T-cell therapy patient monitoring, noncomplete automation of the platform and the absence of a dedicated telemedicine team still represent major limitations to be overcome. This is especially true in our real-life setting where the target population generally comprises patients of older age with a low digital education level.
ABSTRACT
Objetivo: Analizar la validez y la fiabilidad de la adaptación de la escala Perceived Personal Control (PPC) en el contexto español para pacientes portadoras de mutación en los genes BRCA1/2 responsables del cáncer de mama y ovario hereditario (CMOH). Método: Adaptación transcultural y validación de la escala Perceived Personal Control (PPC) desarrollada por Shiloh y colaboraradores mediante traducción, retrotraducción y validación a través de un análisis factorial exploratorio con rotación Oblimin en una muestra de 176 mujeres portadoras de genes BRCA 1/2 para CMOH. Resultados: La versión española de la PPC reduce a seis los nueve ítems de la escala original, dado que esta estructura es la que ofrece una solución factorial más satisfactoria. El análisis factorial mostró un solo factor que explica el 51,07% de la varianza, en el que todos los ítems tenían cargas factoriales por encima de 0,4. El coeficiente α de Cronbach fue de 0,84 para el conjunto de la escala, la cual permite obtener valores que oscilan entre 0 (bajo grado de percepción de control) y 2 (alto grado de percepción de control). Conclusiones: La adaptación española de la Escala de Percepción de Control (PPC6) posee propiedades psicométricas satisfactorias en la versión de 6 ítems con un solo factor, por lo que su utilización en contexto español Consejo Genético para cáncer hereditario parece adecuada (AU)
Purpose: The aim of this study was to analyze the reliability and validity of the spanish adaptation of the Perceived Personal Control (PPC) scale in women who were positive for BRCA1/2 genes, which are related with hereditary ovarian and breast cancer (HOBC). Method: PPC original items developed by Shiloh and co-workers were translated and back-translated in order to develop an spanish version which was analyzed by an exploratory factor analysis with Oblimin rotation. Answers to the spanish version were provided by a sample of 176 women who were positive for BRCA1/2 for HOBC. Results: Spanish version contains only six items of the nine original items, since this structure provided the optimal solution to the exploratory factor analysis. This version is a one-factor scale (51.07% of variance explained) and all items had factor loading values >0.4. The scale has good reliability (Cronbach's Alpha =0.84) and gives a range of values between 0 (low perceived control) and 2 (high perceived control). Conclusions: Spanish adaptation (PPC6) of the original 9-items version has enough reliability and psychometric properties, and it seems to be useful to be applied in Genetic Counseling at spanish cultural settings (AU)
