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Trial Title:
Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1
NCT ID:
NCT06305117
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
quality of life
virtual reality
music
feasibility study
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Distraction strategy
Description:
Distraction strategy combining the use of virtual reality and music
Arm group label:
Participants
Summary:
The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate
the feasibility of implementing in day patient chemotherapy units a distraction strategy
combining virtual reality (VR) and music which fits the needs of both breast cancer
patients and healthcare providers (i.e., strategy administrators), and to evaluate its
impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii)
nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality
of life.
The present project is a non-randomized non-controlled prospective monocentric
feasibility study which will focus on evaluating the feasibility of implementing the
strategy in the target population and setting.
In the case that implementation of a distraction strategy combining virtual reality and
music to improve quality of life of breast cancer patients during chemotherapy is deemed
feasible, the efficacy of using this strategy to improve patients' experience of
chemotherapy and long-term quality of life will be evaluated in a future randomized
controlled trial informed and optimized by the results of the present work.
Detailed description:
VRtuose (phase 1) is a non-randomized, single-centre, prospective, feasibility study
conducted in the day patient chemotherapy unit of the Centre Léon Bérard in Lyon. This
study will include women diagnosed with breast cancer who are receiving or are planned to
receive any chemotherapy regimen. As this is a feasibility study, there will be no
control group and all participants will be offered the intervention.
The intervention will be implemented from the first chemotherapy session onwards until it
has been offered at four distinct chemotherapy sessions or until the end of patients'
chemotherapy course if it is ended earlier. The intervention will be offered in addition
to the standard of care at the study hospital.
All women with breast cancer who are about to start or who have started chemotherapy will
be considered for inclusion in the study. All participants will be offered the
distraction strategy for four consecutive chemotherapy sessions spanning over their
chemotherapy course (i.e., from the first session onwards) whenever the strategy is
available for use.
The intervention will be characterised by a strategy combining immersive virtual reality
and music delivered during chemotherapy sessions to breast cancer patients by trained
oncology nurses. Different immersive environments and of music will be available to the
choice of the patient. From the first chemotherapy session onwards, patients will be
offered by oncology nurses to use the distraction strategy during their chemotherapy
session. Patients who are willing to use the strategy will have the possibility to choose
the content of the strategy and to use it for the duration of their choice. Patients will
be followed up from recruitment until they have been offered four times to use the
strategy (or until the end of their chemotherapy course if it ends earlier).
This study will assess the feasibility to implement such a strategy into a day-hospital
chemotherapy unit at a major oncology centre, and will therefore collect information on
feasibility, acceptability and tolerability outcomes of using the strategy in this
context. The efficacy of the strategy to improve patients' quality of life will not be
evaluated in this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of breast cancer;
- Any disease stage;
- Patient must be receiving (i.e., with at least 4 remaining cures) or about to start
palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer
at Centre Léon Bérard;
- Willingness and ability to comply with the study requirements;
- Patient must be covered by a medical insurance;
- Patient must understand, speak, read and write French.
Exclusion Criteria:
- History of condition contraindicating the use of virtual reality (e.g., epilepsy,
severe motion sickness);
- Brain metastases;
- Any medical or psychosocial condition that would compromise the patient's compliance
to the study procedures or would likely interfere with the completion of
Patient-Reported Outcomes;
- Patients under tutorship or curatorship;
- Patients already included in another clinical trial ongoing at Centre Léon Bérard.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Contact:
Last name:
Olivier Trédan, MD
Email:
olivier.tredan@lyon.unicancer.fr
Investigator:
Last name:
Olivier Trédan, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
May 2025
Lead sponsor:
Agency:
International Agency for Research on Cancer
Agency class:
Other
Collaborator:
Agency:
Centre Leon Berard
Agency class:
Other
Source:
International Agency for Research on Cancer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06305117