Digital health intervention to support breast cancer patients
Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients
This study is testing a new digital tool to help breast cancer patients in Mexico by providing them with better support and monitoring compared to standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Mexico, Ciudad De México and 2 other locations) |
| Trial ID | NCT05925257 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve care for breast cancer patients in Mexico by implementing a digital health intervention that includes a responsive web application for monitoring electronic patient-reported outcomes (ePROs) and proactive follow-up by nurses. The study will randomly assign participants to either the intervention group, which receives the ePRO application and additional support, or a control group that receives standard health information. The trial will assess the usability and effectiveness of this intervention over a six-month period, with additional follow-up for three months. The goal is to address the unmet supportive care needs of breast cancer patients in a setting where such interventions have not been previously tested.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 to 75 with stages I, II, or III breast cancer who are undergoing neoadjuvant or adjuvant chemotherapy and have internet access.
Not a fit: Patients with stage IV breast cancer, cognitive dysfunction, or severe depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of care and support for breast cancer patients, leading to better health outcomes.
How similar studies have performed: While this specific approach has not been tested in Mexico, similar interventions in high-income settings have shown success in improving patient-centered care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women * Age between 20 and 75 years * Breast cancer stages I, II, or III * Neoadjuvant or adjuvant treatment with chemotherapy that started within two to six weeks before enrollment * Access to the internet on mobile phone, computer or tablet * Written informed consent Exclusion Criteria: * Illiterate * Stage IV breast cancer * Cognitive dysfunction * Blindness or low vision not corrected with glasses * Severe depression (≥12 points on the Hospital Anxiety and Depression Scale)
Where this trial is running
Mexico, Ciudad De México and 2 other locations
- Hospital de Oncología del Centro Médico Nacional Siglo XXI — Mexico, Ciudad De México, Mexico (Recruiting)
- UMAE Hospital de Gineco-Obstetricia No.3 "Dr. Víctor Manuel Espinoza de los Reyes Sánchez" CMN La Raza. — Mexico City, Mexico (Recruiting)
- UMAE Hospital de Especialidades CMN "Gral. de Div. Manuel Ávila Camacho" — Puebla, Mexico (Recruiting)
Study contacts
- Principal investigator: Svetlana V. Doubova, MD. DSc. — Instituto Mexicano del Seguro Social
- Study coordinator: Svetlana V. Doubova, MD. DSc.
- Email: svetlana.doubova@gmail.com
- Phone: +525556276900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.