Evaluation of the RESTART Survival Programme

Free University of Brussels (ULB)

Status: Not yet enrolling

Conditions: Invasive Breast Cancer

Treatments: Other: educational workshops

Study type: Observational

Funder types: Other

Identifiers

NCT06283511

IJB-RESTART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >= 18 at the time of signing the ICF
2. Minimum understanding of French
3. Signed study informed consent form obtained prior to any study-related procedure.
4. Participation in the RESTART programme
5. Patient with curative breast cancer (AJCC stage I-II-III)

Exclusion criteria