Evaluation of the RESTART Survival Programme
ConditionInvasive Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorJules Bordet Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
1. Refusal to participate in the RESTART programme 2. Patients with AJCC stage IV breast cancer will be excluded.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
educational workshops
Other interventionpatient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 programmeSecondary outcomes
1
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 programme2
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 programme3
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 programme4
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 programmeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: