Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial.

Autor:	Contreras Sánchez SE; Epidemiology and Health Services Research Unit CMN Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de Mexico, Mexico., Doubova SV; Epidemiology and Health Services Research Unit CMN Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de Mexico, Mexico svetlana.doubova@gmail.com., Grajales Álvarez R; Oncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, Mexico., Dip Borunda AK; Oncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, Mexico., Martínez Pineda WJ; Radiation Oncology Department, Oncology Hospital CMN Siglo XXI, IMSS, Ciudad de Mexico, Mexico., Nuñez Cerrillo JG; Oncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, Mexico., Silva Bravo F; Oncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, Mexico., Zalapa Velázquez R; Oncology Department, Speciality Hospital CMN Manuel Ávila Camacho, IMSS, Puebla, Puebla, Mexico., Gutiérrez De la Barrera M; Research Division. Oncology Hospital CMN Siglo XXI, Mexican Institute of Social Security, Ciudad de Mexico, Mexico., Leslie HH; Division of Prevention Science, University of California San Francisco, San Francisco, California, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Nov 06; Vol. 13 (11), pp. e077322. Date of Electronic Publication: 2023 Nov 06.
DOI:	10.1136/bmjopen-2023-077322
Abstrakt:	Introduction: Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses. Methods and Analysis: We designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months. Ethics and Dissemination: The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences. Trial Registration Number: NCT05925257. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu