Evaluation of the RESTART Survival Programme

Invasive Breast Cancer Clinical Trial

Official title:

Evaluation of the RESTART Survival Programme

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283511
• Other study ID #: IJB-RESTART
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 after participation in the RESTART programme.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Invasive Breast Cancer

Intervention

Other:
• educational workshops
patient will be proposed to assist to educational workshops + the possibility to assist to a physical rehabilitation programme

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after end of programme and 12 months after end of the programme
Secondary	assessment of quality of life	To measure changes in quality of life via EORTC30 questionnaire	baseline - 1 month after end of programme - 12 months after end of programme
Secondary	assessemnt of health literacy via HLQ questionnaire	to mesure changes in health literacy via HLQ questionnaire	baseline - 1 month after end of programme - 12 months after end of programme
Secondary	assessment of professional status	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
Secondary	assessment of level of physical activity	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
Secondary	assessment of emotionnal distress	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
Secondary	assessment of the intensity of residual fatigue	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
Secondary	assessment of sleep quality	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
Secondary	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.	baseline - 1 month after end of programme - 12 months after end of programme
Secondary	assessment of quality of life	To measure changes in quality of life via BR 23 questionnaire	baseline - 1 month after end of programme - 12 months after end of programme
Secondary	assessment of emotionnal distress	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