Evaluation of the RESTART Survival Programme

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Invasive Breast Cancer

Clinical Trial Details

NCT number	NCT06283511
Study type	Observational [Patient Registry]
Source	Jules Bordet Institute
Contact
Status	Not yet recruiting
Phase
Start date	February 2024
Completion date	December 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03595592` - Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer	Phase 3
Recruiting	`NCT05383196` - Onvansertib + Paclitaxel In TNBC	Phase 1/Phase 2
Recruiting	`NCT06158217` - Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
Active, not recruiting	`NCT04448886` - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC	Phase 2
Completed	`NCT02773784` - Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.
Recruiting	`NCT01509781` - Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	Phase 3
Completed	`NCT04478669` - Digital Breast Tomosynthesis (DBT) to Improve Assessment of Resection Margins in Invasive Breast Cancer
Recruiting	`NCT04553770` - Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer	Phase 2
Recruiting	`NCT04677816` - Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients	Phase 2
Terminated	`NCT01934335` - Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer	Phase 2
Completed	`NCT00507611` - Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients	N/A
Completed	`NCT00581750` - Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ
Completed	`NCT03304171` - Overall Diet Quality and Breast Cancer Risk	N/A
Completed	`NCT03709186` - Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI
Terminated	`NCT03361800` - Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC	Early Phase 1
Recruiting	`NCT04648904` - Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer	Early Phase 1
Recruiting	`NCT06328465` - fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases	N/A
Active, not recruiting	`NCT03109522` - Axillary Reverse Mapping (ARM) Technique	N/A
Recruiting	`NCT03987555` - Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Recruiting	`NCT03497702` - Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer	Phase 2