Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283511
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-26
Brief Title:
Evaluation of the RESTART Survival Programme
Sponsor:
Jules Bordet Institute
Organization:
Jules Bordet Institute
Study Overview
Official Title:
Evaluation of the RESTART Survival Programme
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None