The Immersive Experience of Virtual Reality During Chemotherapy in Patients With Early Breast and Gynecological Cancers: the Patient's Dream Study

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: 3 Virtual Reality headset (VR Headset),

• Registration Number: NCT05234996
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

"Patient's dream" study is a two-arm randomized controlled trial that will be conducted at Regina Elena National Cancer Institute, IRCCS (Rome), from April 2019 to January 2020. Before starting the first course of chemotherapy, patients will be randomly divided to receive the VRE (VRE arm) as "distraction therapy", or to entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences and for the entire duration of administration of the first CT cycle (control arm). A clinical team composed of three oncologists, three psychologists, one nurse and one expert VR operator will support the patients involved in the study.

The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity.

The study will conduct in accordance with the ethical standards as laid down in the Declaration of Helsinki and its later amendments and within the protocol approved by the Central Ethics Committee (Trial registration number: RS 1105/18). A written informed consent will obtain from all participants included in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2021-01-20
• Study Completion: 2021-04-01
• Study First Submitted: 2021-12-31
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

• presenting prior history of seizures;
• disorders of the mood;
• previous history of alcohol and/or drug addiction;
• disorder of vision and eyes;
• history of psychiatric pathologies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	3 Virtual Reality headset (VR Headset),	In control arm, patients will entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences
virtual reality	3 Virtual Reality headset (VR Headset),	In The VRE arm, patients will use Virtual Reality headset (VR Headset), containing a selection of audiovisual productions made with 360 degrees technology and selected on the basis of content, plot and production dynamics. During the entire experience, an operator dedicated to patient care will be present to allow the most possible comfortable experience.

Primary Outcome Measures

Name	Time	Method
evaluation of Quality of life	Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days	Quality of life is evaluate with QLQ-C30- BR23
evaluation of Distress	Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days	Distress is evaluate with HAds questionnaire

Secondary Outcome Measures

Name	Time	Method
Evaluation of Patients Report Outcomes	Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days	This outcomes is evaluated with PROs
Evaluation of Incidence of treatment-emergent adverse events	Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days	this incidence in evaluate and classified with the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Trial Locations

Locations (1)

alessandra Fabi; 🇮🇹 Roma, Italy