Evaluation of the RESTART Survival Programme
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: educational workshops.
- Кому может быть актуально
- Состояния в реестре: Invasive Breast Cancer. Базовые параметры: 18 лет — 99 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.
Подробное описание
Prospective longitudinal, single-centre, non-randomised study for patients who have completed acute treatment (surgery, radiotherapy, chemotherapy) for localised breast cancer within the last 3 months.
In this project, investigtors are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.
The primary objective is to assess satisfaction with participation in the Restart programme and its various components.
Evaluation criteria associated with the primary objective:
Measurement of overall satisfaction and of the various components of the RESTART programme (Likert scale and open questions)
\- Evaluation criteria associated with the secondary objective:
To measure before starting the RESTART programme and 1 and 12 months after the end of the programme:
* Patients' Quality of Life (QoL) (using the EORTC30 and BR23 questionnaires for breast cancer) * Health literacy (via the HLQ questionnaire) * Professional status * Patients' physical activity level via the Global Physical Activity Questionnaire (GPAQ) * Psychological distress, anxiety and depressive symptoms via the Generalized Anxiety Disorder - 7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) questionnaires * Fatigue (via the NRS) * Patient sleep quality using the Pittsburgh Sleep Quality Index (PSQI) To measure the rate of participation in the programme via the proportion of patients who participated in relation to the number of patients operated on for breast cancer located in Bordet during the same period.
Вмешательства
- Другое educational workshops
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Первичные конечные точки
- Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. [Срок оценки: 1 month after end of programme and 12 months after end of the programme]
Вторичные конечные точки (10)
- assessment of quality of life [Срок оценки: baseline - 1 month after end of programme - 12 months after end of programme]
- assessemnt of health literacy via HLQ questionnaire [Срок оценки: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of professional status [Срок оценки: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of level of physical activity [Срок оценки: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of emotionnal distress [Срок оценки: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of the intensity of residual fatigue [Срок оценки: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of sleep quality [Срок оценки: baseline - 1 month after end of programme - 12 months after end of programme]
- Measuring the rate of participation in the programme [Срок оценки: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of quality of life [Срок оценки: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of emotionnal distress [Срок оценки: baseline - 1 month after end of programme- 12 months after end of programme]
Критерии участия
Критерии включения
- Age >= 18 at the time of signing the ICF
- Minimum understanding of French
- Signed study informed consent form obtained prior to any study-related procedure.
- Participation in the RESTART programme
- Patient with curative breast cancer (AJCC stage I-II-III)
Критерии исключения
\-
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06283511 · IJB-RESTART