Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305117
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-22
Brief Title:
Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1
Sponsor:
International Agency for Research on Cancer
Organization:
International Agency for Research on Cancer
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRtuose1
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 ie strategy administrators and to evaluate its impact on patients i perceived anxiety and pain during chemotherapy sessions ii nauseavomiting 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
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 101227 | OTHER_GRANT | Association Ruban Rose | None |