NCT06283511

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

January 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

January 26, 2024

Last Update Submit

February 25, 2025

Conditions

Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • assessment of quality of life

    baseline - 1 month after end of programme - 12 months after end of programme

  • assessemnt of health literacy via HLQ questionnaire

    baseline - 1 month after end of programme - 12 months after end of programme

  • assessment of professional status

    baseline - 1 month after end of programme- 12 months after end of programme

  • assessment of level of physical activity

    baseline - 1 month after end of programme- 12 months after end of programme

  • assessment of emotionnal distress

    baseline - 1 month after end of programme- 12 months after end of programme

  • +5 more secondary outcomes

Interventions

educational workshopsOTHER

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

Also known as: physical rehabilitation programme

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 28, 2024

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share