An observational study in Invasive Breast Cancer, sponsored by Jules Bordet Institute. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Jules Bordet Institute · Observational
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.
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)
To measure before starting the RESTART programme and 1 and 12 months after the end of the programme:
Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Also known as: physical rehabilitation programme
Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions.
To assess the global satisfaction with participation in the Restart programme and its various components via the Likert Scale.
Time frame: 1 month after end of programme and 12 months after end of the programme
assessment of quality of life
To measure changes in quality of life via EORTC30 questionnaire
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
assessemnt of health literacy via HLQ questionnaire
to mesure changes in health literacy via HLQ questionnaire
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
assessment of professional status
to assess the number of patients who return to work via open question
Time frame: baseline - 1 month after end of programme- 12 months after end of programme
assessment of level of physical activity
to measure the changes in level of physical activity via the Global Physical Activity Questionnaire (GPAQ)
Time frame: baseline - 1 month after end of programme- 12 months after end of programme
assessment of emotionnal distress
to measure the changes in emotional distress via questionnaire "generalized Anxiety Disorder" (GAD-7)
Time frame: baseline - 1 month after end of programme- 12 months after end of programme
assessment of the intensity of residual fatigue
to measure the intensity of residual fatigue via NRS (0= no fatigue and 10 = worst fatigue)
Time frame: baseline - 1 month after end of programme- 12 months after end of programme
assessment of sleep quality
changes in sleep quality via Pittsburgh sleep Quality index (PSQI) before and after participation in the RESTART programme.
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
Measuring the rate of participation in the 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.
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
assessment of quality of life
To measure changes in quality of life via BR 23 questionnaire
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
assessment of emotionnal distress
to measure the changes in emotional distress via questionnaire "Patient Health Questionnaire-9" (PHQ-9)
Time frame: baseline - 1 month after end of programme- 12 months after end of programme
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Jules Bordet Institute