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NCT Number: NCT06283511

Evaluation of the RESTART Survival Programme

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

educational workshops

Other

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

Other names: physical rehabilitation programme

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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.

  9. 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

  10. 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)

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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