To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluation of the RESTART Survival Programme
NCT ID:
NCT06283511
Condition:
Invasive Breast Cancer
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
educational workshops
Description:
patient will be proposed to assist to educational workshops + the possibility to assist
to a physical rehabilitation programme
Other name:
physical rehabilitation programme
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.
Criteria for eligibility:
Study pop:
1. Refusal to participate in the RESTART programme
2. Patients with AJCC stage IV breast cancer will be excluded.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age >= 18 at the time of signing the ICF
2. Minimum understanding of French
3. Signed study informed consent form obtained prior to any study-related procedure.
4. Participation in the RESTART programme
5. Patient with curative breast cancer (AJCC stage I-II-III)
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Start date:
February 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06283511
