Clinical trial NCT06002022: Evaluation of Improvements in Patient-reported Quality of Life
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Quality of Life
Physical Activity
Sleep Quality
Stress
Pain
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Resting quality
timeFrame: 18 months follow up since enrolment with a monthly measurement
measure: Stress level
timeFrame: 18 months follow up since enrolment with a monthly measurement
measure: Stress level related to illness
timeFrame: 18 months follow up since enrolment with a monthly measurement
measure: Pain level of the last 24 hours
timeFrame: 18 months follow up since enrolment with a monthly measurement
measure: Tiredness level of the last 24 hours
timeFrame: 18 months follow up since enrolment with a monthly measurement
Secondary outcomes:
measure: Weight
timeFrame: 18 months follow up since enrolment
measure: Height
timeFrame: 18 months follow up since enrolment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: