Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1

NCT06305117 | Completed

• 2 other identifiers: PP202304-37-1101227
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

quality of life; virtual reality; music; feasibility study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Accessibility of the strategy

  Through study completion, an average of 8 months.

• Duration of use of the strategy by patients

  Through study completion, an average of 8 months.

• Type of video content chosen by participants

  Through study completion, an average of 8 months.

• Type of music content chosen by participants

  Through study completion, an average of 8 months.

• Patients' perception of factors limiting the use of the strategy

  Measured at first use of the strategy and at the end of the study follow-up

Other Outcomes (3)

• Acceptance rate to fill in questionnaires measuring clinical outcomes

  Through study completion, an average of 8 months.

• Time taken to fill in questionnaires measuring clinical outcomes

  Through study completion, an average of 8 months.

• Completeness of questionnaires measuring clinical outcomes

  Through study completion, an average of 8 months.

Study Arms (1)

Participants

EXPERIMENTAL

As this is a feasibility study, all patients included in this study will be offered the intervention.

Other: Distraction strategy

Interventions

Distraction strategy OTHER

Distraction strategy combining the use of virtual reality and music

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Centre Leon Berard: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pauline Boucheron, MD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral scientist

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 12, 2024
• Study Start: November 20, 2024
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)