Clinical trial NCT06283511: Evaluation of the RESTART Survival Programme
Official title: Evaluation of the RESTART Survival Programme
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Invasive Breast Cancer
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions.
timeFrame: 1 month after end of programme and 12 months after end of the programme
Secondary outcomes:
measure: assessment of quality of life
timeFrame: baseline - 1 month after end of programme - 12 months after end of programme
measure: assessemnt of health literacy via HLQ questionnaire
timeFrame: baseline - 1 month after end of programme - 12 months after end of programme
measure: assessment of professional status
timeFrame: baseline - 1 month after end of programme- 12 months after end of programme
measure: assessment of level of physical activity
timeFrame: baseline - 1 month after end of programme- 12 months after end of programme
measure: assessment of emotionnal distress
timeFrame: baseline - 1 month after end of programme- 12 months after end of programme
measure: assessment of the intensity of residual fatigue
timeFrame: baseline - 1 month after end of programme- 12 months after end of programme
measure: assessment of sleep quality
timeFrame: baseline - 1 month after end of programme - 12 months after end of programme
measure: Measuring the rate of participation in the programme
timeFrame: baseline - 1 month after end of programme - 12 months after end of programme
measure: assessment of quality of life
timeFrame: baseline - 1 month after end of programme - 12 months after end of programme
measure: assessment of emotionnal distress
timeFrame: baseline - 1 month after end of programme- 12 months after end of programme
Other outcomes:
Locations:
Study officials:
References: