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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.
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Background: Receiving a diagnosis of lung cancer is an emotional event, not least because it is usually diagnosed at advanced stages with limited life expectancy. Although evidence-based educational, emotional, and social interventions exist, they reach few patients and usually when it is too late. Objective: This project will be carried out in a comprehensive center for cancer care and health research, aiming to study the efficacy, costs, and utility of an eHealth ecosystem to meet the psychosocial needs of patients with advanced lung cancer. Method: We will enroll 76 patients with advanced lung cancer into an eHealth ecosystem of stepped and personalized psychosocial care for 9 months. These patients will be compared with another 76 receiving usual care in a non-inferiority randomized controlled trial. The following main outcomes will be measured every 3 months: emotional distress, spirituality, demoralization, quality of life, and medication adherence. Secondary outcomes will include symptomatology, health education, cost-utility analyses, usability and satisfaction with the platform, and time to detect emotional needs and provide care. Baseline differences between groups will be measured with the Student t-test or chi-square test, as appropriate. We will then compare the main outcomes between groups over time using multilevel linear models, report effect sizes (Hedges' g), and assess non-inferiority. The cost-utility of both interventions will be considered in terms of quality adjusted life years and quality of life given the costs of providing each treatment. Discussion: This randomized controlled trial should provide new evidence on the efficacy and cost-utility of an eHealth ecosystem to deliver personalized and timely psychosocial care to patients with advanced lung cancer. Trial registration: ClinicalTrials.gov ID "NCT05497973".
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Health education and psychosocial interventions prevent emotional distress, and the latter has been shown to have an impact on survival. In turn, digital health education interventions may help promote equity by reaching a higher number of cancer patients, both because they avoid journeys to the hospital, by and having a better efficiency. A total of 234 women recently diagnosed with breast cancer in a comprehensive cancer center used the digital ecosystem ICOnnecta't from March 2019 to March 2021. ICOnnecta't consists of four care levels, provided to patients according to their level of distress. The second level of this intervention consists of an educational campus, which was analyzed to track users' interests and their information-seeking behavior. Overall, 99 out of 234 women (42.3%) used the educational campus. There were no significant differences in sociodemographic and clinical variables between the campus users and non-users. Among users, the median number of resources utilized per user was four (interquartile range: 2−9). Emotional and medical resources were the contents most frequently viewed and the audiovisual format the most consulted (p < 0.01). Resources were used mainly within the first three months from enrolment. Users who were guided to visit the virtual campus were more active than spontaneous users. Offering an early holistic health educational platform inside a digital cancer ecosystem, with health professionals involved, can reach more patients, promoting equity in the access of cancer information and prevention, from the very beginning of the disease.
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Background/Objective: Environmental factors such as psychosocial stress have demonstrated to have an impact on the breast cancer (BC) course. This study aims to explore the impact of psychotherapy and stressful life events (SLE) on BC survivors' illness trajectories. Method: 68 women with BC underwent Positive Psychotherapy or Cognitive-Behavioral Stress Management and 37 patients were included as a control group. The effects of distress reduction and SLE on their 5-year recurrence were investigated. Additional analyses examined the effect of receiving vs. not receiving psychotherapy and of the type of therapy on survival and disease-free interval, DFI. Results: A one-point decrease of the Hospital Anxiety and Depression Scale (HADS) after psychotherapy predicted a lower risk of 5-year recurrence, OR = 0.84, p = .037, 95% CI = 0.71-0.99). Also, a one point-increase in the number threatening SLE (OR = 1.92; p = .028, 95% CI = 1.07-3.43) was related to higher 5-year recurrence. Conclusions: The findings highlight the necessity of studying not only a given situation (i.e., psychotherapy, SLE) but its specific impact on individuals.
Antecedentes/Objetivo: El estrés psicosocial ha demostrado tener un impacto en la evolución del cáncer de mama (CM). Este estudio tiene como objetivo explorar el impacto de la psicoterapia y de los acontecimientos vitales estresantes (AVE) en la supervivencia de pacientes con CM. Método: 113 mujeres con CM recibieron psicoterapia positiva o terapia cognitivo-conductual para manejar el estrés y 37 se incluyeron como grupo control. Se analizaron los efectos de la reducción de la Escala de Ansiedad y Depresión Hospitalaria (HADS) y de los AVE sobre la recurrencia a los cinco años, así como el efecto de recibir psicoterapia y del tipo de enfoque d esta sobre la supervivencia. Resultados: La reducción de un punto en la HADS después de recibir psicoterapia predijo un menor riesgo de recurrencia, OR = 0,84, p = 0,037, IC 95% = 0,71-0,99. Además, cada aumento en el número de AVE vividos como amenazantes (OR = 1,92; p = 0,028, 95% CI = 1,07-3,43) se relacionó con una mayor recurrencia. Conclusiones: Los resultados indican la necesidad de estudiar no solo la presencia de un evento potencialmente impactante en la conducta (psicoterapia o AVE) sino el efecto especifico que ha tenido en cada individuo.
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AbstractBackground/Objective: Environmental factors such as psychosocial stress have demonstrated to have an impact on the breast cancer (BC) course. This study aims to explore the impact of psychotherapy and stressful life events (SLE) on BC survivors illness trajectories. Method: 68 women with BC underwent Positive Psychotherapy or Cognitive-Behavioral Stress Management and 37 patients were included as a control group. The effects of distress reduction and SLE on their 5-year recurrence were investigated. Additional analyses examined the effect of receiving vs. not receiving psychotherapy and of the type of therapy on survival and disease-free interval, DFI. Results: A one-point decrease of the Hospital Anxiety and Depression Scale (HADS) after psychotherapy predicted a lower risk of 5-year recurrence, OR = 0.84, p = .037, 95% CI = 0.71-0.99). Also, a one point-increase in the number threating SLE (OR = 1.92; p = .028, 95% CI = 1.07-3.43) was related to higher 5-year recurrence. Conclusions: The findings highlight the necessity of studying not only a given situation (i.e., psychotherapy, SLE) but its specific impact on individuals.
ResumenAntecedentes/Objetivo: El estrés psicosocial ha demostrado tener un impacto en la evo-lución del cáncer de mama (CM). Este estudio tiene como objetivo explorar el impacto de la psicoterapia y de los acontecimientos vitales estresantes (AVE) en la supervivencia de pacientes con CM. Método: 113 mujeres con CM recibieron psicoterapia positiva o terapia cognitivo-conductual para controlar el estrés y 37 se incluyeron como grupo con-trol. Se analizaron los efectos de la reducción de la Escala de Ansiedad y Depresión Hos-pitalaria (HADS) y de los AVE sobre la recurrencia a los cinco años, así como el efecto de recibir psicoterapia y del tipo de enfoque sobre la supervivencia. Resultados: La reduc-ción de un punto en la HADS después de recibir psicoterapia predijo un menor riesgo de recurrencia, OR = 0,84, p = 0,037, IC 95% = 0,71-0,99. Además, cada aumento en el nú-mero de AVE vividos como amenazantes (OR = 1,92; p = 0,028, 95% CI = 1,07-3,43) se relacionó con una mayor recurrencia. Conclusiones: Los resultados indican la necesidad de estudiar no solo la presencia de un evento potencialmente impactante en la conducta (psicoterapia o AVE) sino el efecto específico que ha tenido en cada individuo.
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Humanos , Femenino , Neoplasias de la Mama/psicología , Accidente Cerebrovascular , Ansiedad , Depresión , Psicoterapia , Terapia Cognitivo-ConductualRESUMEN
Psychosocial interventions prevent emotional distress and facilitate adaptation in breast cancer (BC). However, conventional care presents accessibility barriers that eHealth has the potential to overcome. ICOnnecta't is a stepped digital ecosystem designed to build wellbeing and reduce psychosocial risks during the cancer journey through a European-funded project. Women recently diagnosed with BC in a comprehensive cancer center were offered the ecosystem. ICOnnecta't consists of four care levels, provided according to users' distress: screening and monitoring, psychoeducation campus, peer-support community, and online-group psychotherapy. Descriptive analyses were conducted to assess the platform's implementation, while multilevel linear models were used to study users' psychosocial course after diagnosis. ICOnnecta't showed acceptance, use and attrition rates of 57.62, 74.60, and 29.66%, respectively. Up to 76.19% of users reported being satisfied with the platform and 75.95% informed that it was easy to use. A total of 443 patients' needs were detected and responsively managed, leading 94.33% of users to remain in the preventive steps. In general, strong social support led to a better psychosocial course. ICOnnecta't has been successfully implemented. The results showed that it supported the development of a digital relation with healthcare services and opened new early support pathways.
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INTRODUCTION: Psychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost-utility. METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients' satisfaction and usability. For the cost-utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs. ETHICS AND DISSEMINATION: This study was approved by the Ethics committee of the Institut Català d'Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases. TRIAL REGISTRATION NUMBER: Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.
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Neoplasias de la Mama , Supervivientes de Cáncer , Telemedicina , Neoplasias de la Mama/terapia , Análisis Costo-Beneficio , Ecosistema , Humanos , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , EspañaRESUMEN
INTRODUCCIÓN: A pesar de que los tratamientos psico-oncológicos han demostrado su efectividad en disminuir el malestar emocional y mejorar la calidad de vida de las personas con cáncer, aún existen numerosas barreras que limitan su acceso. La transformación a online de esta atención se plantea como una solución para aumentar la cobertura del servicio y mejorar su coste-utilidad. OBJETIVO: Crear un ecosistema digital de salud para reducir el impacto del cáncer, aumentando el bienestar y la calidad de vida del ciudadano con cáncer. MÉTODO: Programa dirigido a pacientes diagnosticadas de cáncer de mama en fase de supervivencia aguda. Es un programa de atención escalonada dividido en 4 niveles de intervención jerarquizados por complejidad: Nivel 1, cribado y monitorización psicosocial; Nivel 2, Campus: psicoeducación y educación sanitaria; Nivel 3, soporte psicosocial comunitario; y Nivel 4, tratamiento psicoterapéutico grupal. RESULTADOS: En 2019, 259 mujeres fueron incluidas en el programa (39,91% de los nuevos casos de cáncer de mama en los centros participantes). Solo el 3,47% (n = 9) requirió atención clínica especializada (Nivel 4). CONCLUSIÓN: El programa Iconnecta't adopta un modelo integrado de atención psicosocial en cáncer que se adecúa a las necesidades específicas de los supervivientes. Da solución a algunas de las barreras de la atención sanitaria tradicional, democratizando el acceso a los servicios mediante el uso de tecnologías de uso común en la mayoría de ciudadanos. En un futuro próximo se prevé la implementación progresiva a otras neoplasias, junto con un ensayo clínico controlado y aleatorizado que evaluará su eficacia
INTRODUCTION: Although psycho-oncological treatments have already demonstrated their effectiveness in reducing emotional distress and improving quality of life in people with cancer, there are still numerous barriers limiting their access. The digital transformation of care is proposed as a solution to increase service coverage and improve its cost-utility. AIM: Create a digital health ecosystem to reduce the impact of cancer, increasing users' well-being and quality of life. METHOD: The program is addressed to patients diagnosed with breast cancer in the acute survival phase. It is a stepped-care intervention divided into 4 levels ordered by complexity: Level 1, psychosocial screening and monitoring; Level 2, Campus: psychoeducation and health education; Level 3, psychosocial community support; and Level 4, psychotherapeutic group treatment. RESULTS: In 2019, 259 women were included in the program (39.91% of new breast cancer cases in participating centers), and only 3.47% (n = 9) required specialized clinical care (Level 4). CONCLUSIONS: The Iconnecta't program adopts an integrated model of psychosocial care in cancer that adapts to survivors' specific needs. It overcomes some of the barriers of traditional healthcare, democratizing service access through the use of common technologies among the vast majority of citizens. In the near future, progressive implementation to other cancer diagnoses is planned, together with a randomized controlled trial to evaluate its effectiveness
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Humanos , Femenino , Aplicaciones de la Informática Médica , Telemedicina/instrumentación , Neoplasias de la Mama/psicología , Calidad de Vida , Psicooncología/métodos , Psicoterapia de Grupo , Europa (Continente)RESUMEN
OBJECTIVE: To study the impact of the spontaneous use of Internet on breast cancer patients and on their relationship with health professionals. METHODS: A mixed methodology was used. Two questionnaires were designed through three focus groups, and then administered to 186 patients and 59 professionals in order to assess: (1) patients' use of Internet for health-related information and (2) the impact of this information on patients' psychological outcomes and on their relationship with professionals. RESULTS: Patients spent more time looking for illness-related information after diagnosis, using interactive communities more than static information websites. Patients and professionals disagreed about the use of Internet in terms of the knowledge it provides, and its psychological impact. The main barrier reported by patients regarding the sharing of online information with their professionals was the belief that it would damage their relationship. CONCLUSIONS: Both professionals and patients have a protectionist conception of the therapeutic relationship. This attitude tends to dismiss the positive impact that the use of Internet and the new communication tools may have in cancer patients. New resources should provide an "Internet Prescription" and modes of interaction to facilitate a more open digital communication.
