Clinical trial · Interventional
Digital Health Intervention to Improve Health Care and Outcomes for Breast Cancer Patients
Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, 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. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention. Methods. The investigators 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. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized 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 six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ePRO application and proactive clinical care with nurses. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months.
- interventionNames
- Other: ePRO application and proactive clinical care with nurses.
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions.
Primary outcomes (1)
- measure
- Health systems and information supportive care needs
- timeFrame
- At 1, 3, 6 and 9 months after intervention commencement
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDContreras-Sanchez SE, Doubova SV, Grajales-Alvarez R, Villalobos-Valencia R, Dip-Borunda AK, Nunez-Cerrillo JG, Huerta-Lopez AD, Montiel-Jarquin AJ, Garcia-Galicia A, Talamantes-Gomez EI, Sanchez-Reyes RI, Aguirre-Gomez J, Gonzalez-Santiesteban S, Molina-Perez CJ, Leslie HH. Effectiveness of a digital health intervention on the supportive care needs and quality of life in Mexican patients with breast cancer: a randomized clinical trial. BMC Cancer. 2026 Feb 16;26(1):391. doi: 10.1186/s12885-026-15724-w. PMID 41692765
- DERIVEDContreras Sanchez SE, Doubova SV, Martinez Vega IP, Grajales Alvarez R, Villalobos Valencia R, Dip Borunda AK, Lio Mondragon L, Martinez Pineda WJ, Nunez Cerrillo JG, Huerta Lopez AD, Zalapa Velazquez R, Mendoza Ortiz V, Vazquez Zamora VJ, Montiel Jarquin AJ, Garcia Galicia A, Talamantes Gomez EI, Sanchez Reyes R, Aguirre Gomez J, Ayala Anzures ME, Zapata Tarres M, Monroy A, Leslie HH. Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention. BMJ Open. 2024 Jun 21;14(6):e087240. doi: 10.1136/bmjopen-2024-087240. PMID 38908841
- DERIVEDContreras Sanchez SE, Doubova SV, Grajales Alvarez R, Dip Borunda AK, Martinez Pineda WJ, Nunez Cerrillo JG, Silva Bravo F, Zalapa Velazquez R, Gutierrez De la Barrera M, Leslie HH. 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. BMJ Open. 2023 Nov 6;13(11):e077322. doi: 10.1136/bmjopen-2023-077322. PMID 37931967