Evaluation of Improvements in Patient-reported Quality of Life

Trial Title: Evaluation of Improvements in Patient-reported Quality of Life

NCT ID: NCT06002022

Condition: Breast Cancer
Quality of Life
Physical Activity
Sleep Quality
Stress
Pain

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Control arm: Patients will be treated as usual after the first-line breast cancer treatment. Specifically, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations. Experimental arm: Additionally, patients will be trained in the use of the REBECCA mobile and online monitoring platform, which will be used longitudinally, with the collection of real-world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, which provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: REBECCA system (smartwatch + mobile app use)
Description: 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
Arm group label: Standard treatment + REBECCA

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

Detailed description: 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: - Improves the quality of the provided treatment at 12 months, resulting in an improved QoL, in comparison with standard treatment practice It will also evaluate that: - The observed improvements will persist long-term, at least till the point of the 18-month follow-up evaluation - The observed QoL improvements will be associated with REBECCA's Functional Life Index improvements, as evaluated through the continuous REBECCA real world measurements. This will act as an assessment of the RWD use for safer and more effective post-treatment management of interventions with first line chemo/radiotherapies in breast cancer. - The observed QoL improvements will be associated with REBECCA's PROM Index improvements, as evaluated through the continuous REBECCA real world measurements.

Criteria for eligibility:
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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Clínico Universitario de Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Status: Recruiting

Contact:
Last name: Tania Fleitas, MD, PhD

Phone: +34 616315091
Email: tfleitask@gmail.com

Start date: January 1, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Cristina Hernando
Agency class: Other

Source: Fundación para la Investigación del Hospital Clínico de Valencia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06002022
http://rebeccaproject.eu/