Идёт набор NCT06002022

Evaluation of Improvements in Patient-reported Quality of Life

Без фазы С лечением Breast Cancer Quality of Life Physical Activity Sleep Quality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: REBECCA system (smartwatch + mobile app use).
Кому может быть актуально: Состояния в реестре: Breast Cancer, Quality of Life, Physical Activity, Sleep Quality. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

Устройство 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 sy

Первичные конечные точки

Resting quality [Срок оценки: 18 months follow up since enrolment with a monthly measurement]
Stress level [Срок оценки: 18 months follow up since enrolment with a monthly measurement]
Stress level related to illness [Срок оценки: 18 months follow up since enrolment with a monthly measurement]
Pain level of the last 24 hours [Срок оценки: 18 months follow up since enrolment with a monthly measurement]
Tiredness level of the last 24 hours [Срок оценки: 18 months follow up since enrolment with a monthly measurement]

Вторичные конечные точки (2)

Weight [Срок оценки: 18 months follow up since enrolment]
Height [Срок оценки: 18 months follow up since enrolment]

Критерии участия

Критерии включения

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.