Improving quality of life for breast cancer patients using real-world data
Local Intervention Trial for the Evaluation of Improvements in Patient-reported Quality of Life and Treatment Satisfaction in BCP as a Result of Flexible Treatment Planning Supported by REBECCA-collected RWD
This study tests if using the REBECCA system to provide support for breast cancer patients after treatment can improve their quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06002022 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on enhancing the quality of life for breast cancer patients through the use of the REBECCA system, which collects real-world data to inform treatment planning. Patients will receive just-in-time support consultations during the first year after their chemotherapy or radiotherapy. The study compares the outcomes of patients using the REBECCA system against those receiving standard care, assessing improvements in quality of life and treatment satisfaction. Long-term effects will also be evaluated at an 18-month follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage I-III breast cancer who have undergone endocrine treatment within the last 12 months.
Not a fit: Patients who are unwilling to provide informed consent or have conditions that may hinder compliance with the study protocol may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for breast cancer patients post-treatment.
How similar studies have performed: Other studies utilizing real-world data to improve patient outcomes have shown promise, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Before patient registration, written informed consent must be given according to national and local regulations. * Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization. * Be between 18 and 75 years of age. * Have increased life expectancy beyond the initial 3 months post-treatment initiation. * Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Exclusion Criteria: * Patients that are not willing to sign an informed consent form
Where this trial is running
Valencia
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
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.