Web and mobile program to help long-term breast cancer survivors manage late effects
Official title: A Web-based Tailored Intervention to Improve the Quality of Life of Long-term Breast Cancer Survivors. A Randomized Controlled Trial
Run by Fundacion Miguel Servet · NCT05322460 · Data updated 2026-11-12
This web and mobile program will be tried to see if personalized, AI-driven guidance delivered through primary care helps women five or more years after breast cancer treatment manage physical, emotional, and social late effects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 182 (estimated) |
| Sponsor | Fundacion Miguel Servet Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pamplona) |
| Status | Recruiting |
| Started | December 15, 2023 |
| Main results expected | September 30, 2025 |
| Study ends | November 2025 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT05322460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who were diagnosed with breast cancer, completed active treatment more than five years ago, are currently disease-free, and are comfortable using the Internet are ideal candidates.
✕Probably not a fit
Men, people with recurrent or metastatic disease, those currently receiving active cancer treatment, or people who cannot use Spanish-language web/mobile tools may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project will design a personalized digital intervention (web/mobile) using algorithms to tailor content to long-term breast cancer survivors' needs, then pilot and test it in a randomized controlled trial following the Medical Research Council framework. Phase I involves expert-informed content design based on a review of survivors' needs; Phase II includes a pilot pretest–posttest; a full RCT will compare the web-based program delivered via primary care against usual primary care. Primary outcomes include quality of life and self-efficacy for managing late sequelae, collected with validated measures. The intervention aims to improve continuity between oncology and primary care by providing tailored self-management support remotely.
Why it matters
Potential benefit: If successful, the program could improve survivors' quality of life and confidence in managing long-term physical and psychological effects while strengthening follow-up in primary care.
How similar studies have gone: Previous web-based survivorship and self-management programs have shown mixed but often promising improvements in quality of life and self-efficacy, while AI-tailored interventions in this specific population remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * having been diagnosed with breast cancer * having completed active oncological treatments (chemotherapy and/or radiotherapy) in a period of time greater than five years, * be free of disease at the time of data collection * be a woman and over 18 years of age * have knowledge of Internet use. Exclusion Criteria: * Women with a diagnosis of cancer other than breast cancer * Recurrence of cancer or metastasis that causes a new treatment * Being in active treatment for recurrence or new cancer * Being a man
Where it's running
-
Public University of Navarre
Pamplona, Spain Recruiting
Study contacts
- Principal investigator: Cristina Garcia Vivar, PhD — Universidad Pública de Navarra
- Study coordinator: Cristina García-Vivar, PhD
- Email: cristina.garciavivar@unavarra.es
- Phone: +34948166150
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.