NCT06267014

Brief Summary

The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation. Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

February 9, 2024

Last Update Submit

February 6, 2026

Conditions

Keywords

virtual realitycognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients adhering to the Virtual Reality program

    Adherence is defined as the completion of at least 5 of the 6 sessions planned.

    At 6 weeks

Study Arms (1)

Virtual Reality sessions

EXPERIMENTAL
Behavioral: Virtual Reality sessions

Interventions

One session during 10-15 minutes per week for 6 weeks.

Virtual Reality sessions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18 years of age
  • Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
  • Maximum 2 years after completion of adjuvant treatment,
  • Patients planning to return to work or who have returned to work in the past year,
  • Signature of informed consent prior to any specific procedure relating to the study,
  • Patient affiliated to a social security system.

You may not qualify if:

  • Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
  • Patients with personality disorders and/or psychiatric pathology,
  • Patients deprived of their liberty or placed under the authority of a guardian,
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, France

Location

Related Publications (1)

  • Vieira Jales I, Hummel E, Clarisse B, Gouranton V, Cogne M, Lecuyer A, Leconte A, Lequesne J, Ahmed-Lecheheb D, Morel A, Fernette M, Joly F, Lange M. Virtual reality-based cognitive rehabilitation programme to support employment in patients with breast cancer: protocol for the Cog-RV pilot study. BMJ Open. 2025 Dec 15;15(12):e112196. doi: 10.1136/bmjopen-2025-112196.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

May 23, 2024

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations