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Clinical Trials in Spain / NCT06002022
Recruiting Not applicable

Evaluation of Improvements in Patient-reported Quality of Life

NCT06002022 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Phase
Not applicable
Started
2024-01-01
Last updated
2025-08-06

Condition(s) studied

Breast CancerQuality of LifePhysical ActivitySleep QualityStressPain

Investigational drug(s) / intervention(s)

REBECCA system (smartwatch + mobile app use)

REBECCA system (smartwatch + mobile app use): Patients will be trained in the use of the REBECCA system, which will provide in-depth information about their lifestyle (including physical activity levels, dietary habits, sleep quality and social mobility), as well as of their online behaviour (with outcome indicators of anxiety, PTSD and depression development) and self- or companion-reported measures of emotional state and quality of life. Based on the additional information, exploiting the enhanced monitoring capabilities of the REBECCA system, the supervising clinicians will be given the opportunity to continuously evaluate the progress of the patients, allowing them to schedule up to 3 phone-based consultation sessions in the first 12 months of treatment

Study summary

Local intervention trial for the evaluation of improvements in patient-reported Quality of Life and treatment satisfaction, in breast cancer patients (BCP), as a result of flexible treatment planning supported by REBECCA-collected real-world data, in comparison with standard care

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Resting quality — 18 months follow up since enrolment with a monthly measurement
    Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement. Scale scored from 1-5 (1 not rested, 5 very rested)
  • Stress level — 18 months follow up since enrolment with a monthly measurement
    Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement. Scale scored from 1-5 (1 not stressed, 5 very stressed)
  • Stress level related to illness — 18 months follow up since enrolment with a monthly measurement
    Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement. Scale scored from 1-5 (1 not stressed, 5 very stressed)
  • Pain level of the last 24 hours — 18 months follow up since enrolment with a monthly measurement
    Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement. Scale scored from 1-5 (1 not bad, 5 very bad)
  • Tiredness level of the last 24 hours — 18 months follow up since enrolment with a monthly measurement
    Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement. Scale scored from 1-5 (1 not tired, 5 very tired)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06002022 on ClinicalTrials.gov ↗ ← All trials in Spain