Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1 (VRtuose1)

VRtuose (Virtual RealiTy and mUsic in the Oncology SEtting) : A Single-centre Feasibility Study Evaluating a Strategy Combining Virtual Reality and Music to Improve Quality of Life in Breast Cancer Patients Undergoing Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Distraction strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline Boucheron, MD; Phone Number: +33472738463; Email: boucheronp@iarc.fr
• Study Contact Backup: Name: Valerie McCormack, PhD; Email: mccormackv@iarc.who.int

Study Locations

• France
  • Lyon, France
    • Centre Léon Berard
    • Contact: Olivier Trédan, MD; Email: olivier.tredan@lyon.unicancer.fr
    • Principal Investigator: Olivier Trédan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; As this is a feasibility study, all patients included in this study will be offered the intervention.	Other: Distraction strategy; Distraction strategy combining the use of virtual reality and music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' acceptance rate regarding the use of the distraction strategy.	Average of the number of times the strategy is used by each patient out of the number of chemotherapy cures it is offered to each patient.	Through study completion, an average of 8 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accessibility of the strategy	Percentage of chemotherapy sessions when strategy administrators offer patients to use the strategy.	Through study completion, an average of 8 months.
Duration of use of the strategy by patients	Time elapsed in between start of the first video and end of the last video watched by the participant.	Through study completion, an average of 8 months.
Type of video content chosen by participants	Measured using a questionnaire	Through study completion, an average of 8 months.
Type of music content chosen by participants	Measured using a questionnaire	Through study completion, an average of 8 months.
Patients' perception of factors limiting the use of the strategy	Measured using a questionnaire	Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' perception of factors limiting the use of the strategy	Measured using a questionnaire	One and four months after the start of the study
Workload for strategy administrators	Total time taken by strategy administrators to set up the strategy, explain its functioning to participants and clean it.	Through study completion, an average of 8 months.
Strategy administrators ability to use the strategy	Measured using a questionnaire	Through study completion, an average of 8 months.
Patients' satisfaction regarding the use of the strategy	Measured using a questionnaire	Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' satisfaction regarding the strategy	Measured using a questionnaire	One and four months after the start of the study
Prevalence of adverse events related to the use of the strategy	Percentage of times when use of the strategy is stopped early due to adverse events occurring during its use.	Through study completion, an average of 8 months.
Type of adverse events related to the use of the strategy	Measured using the Simulator Sickness Questionnaire	Through study completion, an average of 8 months.
Severity of adverse events related to the use of the strategy	Measured using the Simulator Sickness Questionnaire	Through study completion, an average of 8 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate to fill in questionnaires measuring clinical outcomes	Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire.	Through study completion, an average of 8 months.
Time taken to fill in questionnaires measuring clinical outcomes	Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire.	Through study completion, an average of 8 months.
Completeness of questionnaires measuring clinical outcomes	Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire.	Through study completion, an average of 8 months.

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Collaborators: Centre Leon Berard
• Investigators: Principal Investigator: Pauline Boucheron, MD, International Agency for Research on Cancer

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; music; virtual reality; feasibility study
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PP202304-37-1; 101227 (Other Grant/Funding Number: Association Ruban Rose)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No