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

  1. Refusal to participate in the RESTART programme
  2. Patients with AJCC stage IV breast cancer will be excluded.

Description

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:

-

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

Jules Bordet Institute

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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