Evaluation of the RESTART Survival Programme
February 25, 2025 updated by: Jules Bordet Institute
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Refusal to participate in the RESTART programme
- Patients with AJCC stage IV breast cancer will be excluded.
Description
Inclusion Criteria:
- 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
- Patient with curative breast cancer (AJCC stage I-II-III)
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions.
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.
|
1 month after end of programme and 12 months after end of the programme
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of quality of life
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
|
baseline - 1 month after end of programme - 12 months after end of programme
|
|
assessemnt of health literacy via HLQ 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
|
baseline - 1 month after end of programme - 12 months after end of programme
|
|
assessment of professional status
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
|
baseline - 1 month after end of programme- 12 months after end of programme
|
|
assessment of level of physical activity
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)
|
baseline - 1 month after end of programme- 12 months after end of programme
|
|
assessment of emotionnal distress
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)
|
baseline - 1 month after end of programme- 12 months after end of programme
|
|
assessment of the intensity of residual fatigue
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)
|
baseline - 1 month after end of programme- 12 months after end of programme
|
|
assessment of sleep quality
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.
|
baseline - 1 month after end of programme - 12 months after end of programme
|
|
Measuring the rate of participation in the 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.
|
baseline - 1 month after end of programme - 12 months after end of programme
|
|
assessment of quality of life
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
|
baseline - 1 month after end of programme - 12 months after end of programme
|
|
assessment of emotionnal distress
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)
|
baseline - 1 month after end of programme- 12 months after end of programme
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 26, 2024
First Submitted That Met QC Criteria
February 22, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 25, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- IJB-RESTART
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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