Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Location status: Recruiting
NCT Number: NCT06002022
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
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Not applicable
Valencia, 46010, Spain
Location status: Recruiting
Local intervention trial which will evaluate the potential of using real-world patient measurements collected by the REBECCA system for improving the patient-reported quality-of-life, through just-in-time support consultations, during the first 12 months after radiology and/or chemotherapy treatment. The effects of the REBECCA-assisted treatment on QoL, in relation to baseline, will be compared against standard
The use of REBECCA-collected patient information by BCP-supervising health professionals (based on the continuous REBECCA real-world measurements), aims to estimate to which extent it:
It will also evaluate that:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 18 months follow up since enrolment
Weight measurement (kg) as part of the anthropometric examination
Time frame: 18 months follow up since enrolment
Height measurement (cm) as part of the anthropometric examination
Fundación para la Investigación del Hospital Clínico de Valencia
Other
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
Acronym: REBECCA-QoL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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