Evaluation of the RESTART Survival Programme
- Conditions
- Invasive Breast Cancer
- Registration Number
- NCT06283511
- Lead Sponsor
- Jules Bordet Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. 1 month after end of programme and 12 months after end of the programme To assess the global satisfaction with participation in the Restart programme and its various components via the Likert Scale.
- Secondary Outcome Measures
Name Time Method assessment of quality of life baseline - 1 month after end of programme - 12 months after end of programme To measure changes in quality of life via BR 23 questionnaire
assessment of sleep quality baseline - 1 month after end of programme - 12 months after end of programme changes in sleep quality via Pittsburgh sleep Quality index (PSQI) before and after participation in the RESTART programme.
assessment of professional status baseline - 1 month after end of programme- 12 months after end of programme to assess the number of patients who return to work via open question
assessment of emotionnal distress baseline - 1 month after end of programme- 12 months after end of programme to measure the changes in emotional distress via questionnaire "Patient Health Questionnaire-9" (PHQ-9)
assessemnt of health literacy via HLQ questionnaire baseline - 1 month after end of programme - 12 months after end of programme to mesure changes in health literacy via HLQ questionnaire
assessment of level of physical activity baseline - 1 month after end of programme- 12 months after end of programme to measure the changes in level of physical activity via the Global Physical Activity Questionnaire (GPAQ)
assessment of the intensity of residual fatigue baseline - 1 month after end of programme- 12 months after end of programme to measure the intensity of residual fatigue via NRS (0= no fatigue and 10 = worst fatigue)
Measuring the rate of participation in the programme baseline - 1 month after end of programme - 12 months after end of programme Measure the participation rate in the program via the proportion of patients who participated compared to the number of patients operated on for breast cancer located in Bordet during the same period.