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NCT05925257
Digital Health Intervention to Improve Health Care and Outcomes for Breast Cancer Patients
Phase 2 trial testing ePRO application and proactive clinical care with nurses. in Breast Cancer in 410 participants. Currently enrolling.
29 December 2024
Quick facts
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 410 |
| Start date | 5 March 2024 |
| Primary completion | 29 December 2024 |
| Estimated completion | 31 March 2025 |
| Sites | 3 locations across Mexico |
Drugs / interventions tested
- ePRO application and proactive clinical care with nurses.
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Coordinación de Investigación en Salud, Mexico — full company profile →
Who can join
Adults 20 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention.
Contreras Sánchez SE, Doubova SV, Martinez Vega IP, Grajales Álvarez R, et al · · 2024 · cited 4× · PMID 38908841 · DOI 10.1136/bmjopen-2024-087240 -
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.
Contreras Sánchez SE, Doubova SV, Grajales Álvarez R, Dip Borunda AK, et al · · 2023 · cited 4× · PMID 37931967 · DOI 10.1136/bmjopen-2023-077322 -
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.
Contreras-Sánchez SE, Doubova SV, Grajales-Álvarez R, Villalobos-Valencia R, et al · · 2026 · PMID 41692765 · DOI 10.1186/s12885-026-15724-w
Verify or expand the search:
- PubMed search for NCT05925257
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Coordinación de Investigación en Salud, Mexico trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05925257 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico
- Last refreshed: 17 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05925257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing