educational workshops
Otherpatient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Other names: physical rehabilitation programme
NCT Number: NCT06283511
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.
Trial opening soon.
Get Notified18 year–99 year
All sexes
Observational
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Other names: physical rehabilitation programme
Time frame: 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.
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
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
to mesure changes in health literacy via HLQ questionnaire
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: baseline - 1 month after end of programme - 12 months after end of programme
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
to measure the changes in emotional distress via questionnaire "Patient Health Questionnaire-9" (PHQ-9)
Jules Bordet Institute
Other
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