NCT06283511

Evaluation of the RESTART Survival Programme

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
OTHER	educational workshops	patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-08-01
• Completion: 2026-12-01
• First posted: 2024-02-28
• Last updated: 2025-02-28