Invasive Breast CancerNCT06283511
Evaluation of the RESTART Survival Programme
An observational study of Invasive Breast Cancer, run by Jules Bordet Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Invasive Breast Cancer
- What is being tested?
- educational workshops
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Dec 2026
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Refusal to participate in the RESTART programme 2. Patients with AJCC stage IV breast cancer will be excluded.
Who may be able to join
- 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)
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Invasive Breast Cancer
- Being tested
- educational workshops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational workshopsOther
Also called physical rehabilitation programme
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after end of programme and 12 months after end of the programme
Secondary outcomes (10)
assessment of quality of life
To measure changes in quality of life via EORTC30 questionnaire
Measured: baseline - 1 month after end of programme - 12 months after end of programme
assessemnt of health literacy via HLQ questionnaire
to mesure changes in health literacy via HLQ questionnaire
Measured: baseline - 1 month after end of programme - 12 months after end of programme
assessment of professional status
to assess the number of patients who return to work via open question
Measured: baseline - 1 month after end of programme- 12 months after end of programme
assessment of level of physical activity
to measure the changes in level of physical activity via the Global Physical Activity Questionnaire (GPAQ)
Measured: baseline - 1 month after end of programme- 12 months after end of programme
assessment of emotionnal distress
to measure the changes in emotional distress via questionnaire "generalized Anxiety Disorder" (GAD-7)
Measured: baseline - 1 month after end of programme- 12 months after end of programme
assessment of the intensity of residual fatigue
to measure the intensity of residual fatigue via NRS (0= no fatigue and 10 = worst fatigue)
Measured: baseline - 1 month after end of programme- 12 months after end of programme
assessment of sleep quality
changes in sleep quality via Pittsburgh sleep Quality index (PSQI) before and after participation in the RESTART programme.
Measured: baseline - 1 month after end of programme - 12 months after end of programme
Measuring the rate of participation in the 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.
Measured: baseline - 1 month after end of programme - 12 months after end of programme
assessment of quality of life
To measure changes in quality of life via BR 23 questionnaire
Measured: baseline - 1 month after end of programme - 12 months after end of programme
assessment of emotionnal distress
to measure the changes in emotional distress via questionnaire "Patient Health Questionnaire-9" (PHQ-9)
Measured: baseline - 1 month after end of programme- 12 months after end of programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283511
- Sponsor's protocol ID
- IJB-RESTART
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the RESTART Survival Programme
- ClinicalTrials.gov ID
- NCT06283511
- Acronym / sponsor ID
- IJB-RESTART
- Conditions
- Invasive Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Refusal to participate in the RESTART programme 2. Patients with AJCC stage IV breast cancer will be excluded.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational workshopsAlso: physical rehabilitation programmepatient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme | Other | – |
Primary outcome
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.
10 secondary outcomes
assessment of quality of life
Time frame: 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
assessment of professional status
Time frame: 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
assessment of emotionnal distress
Time frame: 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
assessment of sleep quality
Time frame: 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
assessment of quality of life
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Invasive Breast Cancer
Recruiting
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Breast Cancer
RecruitingPhase 2
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
RecruitingPhase 1
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
Breast Cancer, Invasive Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Colorectal Cancer, Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer, run by Jules Bordet Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.