Evaluation of the RESTART Survival Programme
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: educational workshops.
- Who it may be relevant to
- Registry conditions: Invasive Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other educational workshops
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Primary outcome measures
- Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. [Time frame: 1 month after end of programme and 12 months after end of the programme]
Secondary outcome measures (10)
- assessment of quality of life [Time frame: baseline - 1 month after end of programme - 12 months after end of programme]
- assessemnt of health literacy via HLQ questionnaire [Time frame: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of professional status [Time frame: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of level of physical activity [Time frame: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of emotionnal distress [Time frame: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of the intensity of residual fatigue [Time frame: baseline - 1 month after end of programme- 12 months after end of programme]
- assessment of sleep quality [Time frame: baseline - 1 month after end of programme - 12 months after end of programme]
- Measuring the rate of participation in the programme [Time frame: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of quality of life [Time frame: baseline - 1 month after end of programme - 12 months after end of programme]
- assessment of emotionnal distress [Time frame: baseline - 1 month after end of programme- 12 months after end of programme]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06283511 · IJB-RESTART