Evaluation of Improvements in Patient-reported Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFundación para la Investigación del Hospital Clínico de Valencia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients that are not willing to sign an informed consent form
Trial design
Design model
Parallel
Treatments tested in this trial
REBECCA system (smartwatch + mobile app use)
DevicePatients 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
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Standard treatmentNo intervention 0 interventions
Group B: Standard treatment + REBECCAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Resting quality
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)
Time frame
18 months follow up since enrolment with a monthly measurement2
Stress level
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)
Time frame
18 months follow up since enrolment with a monthly measurement3
Stress level related to illness
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)
Time frame
18 months follow up since enrolment with a monthly measurement4
Pain level of the last 24 hours
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)
Time frame
18 months follow up since enrolment with a monthly measurementSecondary outcomes
1
Weight
Weight measurement (kg) as part of the anthropometric examination
Time frame
18 months follow up since enrolment2
Height
Height measurement (cm) as part of the anthropometric examination
Time frame
18 months follow up since enrolmentSponsors and contacts
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Source ClinicalTrials.gov