Invasive Breast Cancer
Conditions
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.
Interventions
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Sponsors
Jules Bordet Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 quality of life | baseline - 1 month after end of programme - 12 months after end of programme | To measure changes in quality of life via EORTC30 questionnaire |
| 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) |
| 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. |
| 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. |
| 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 generalized Anxiety Disorder (GAD-7) |
Outcome results
None listed