The Immersive Experience of Virtual Reality During Chemotherapy in Patients With Early Breast and Gynecological Cancers: the Patient's Dream Study
February 9, 2022 updated by: FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
"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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Roma, Italy, 00164
- Alessandra Fabi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- diagnosis of breast or ovarian cancer confirmed histologically, from I to III stage;
- surgery as first therapeutic approach (in case of ovarian cancer, patients with minimal residual disease after surgery will be also included)
- first cycle of adjuvant CT, with or without a biological treatment according to the specific cancer (regimens including anthracyclines/taxanes, anthracyclines/cyclophosphamide, carboplatinum/taxane combined or not with trastuzumab for breast cancer, carboplatin/paclitaxel combined or not with bevacizumab for ovarian cancer);
- aged ≥ 18 years;
- performance status (ECOG) 0-2;
- life expectancy > 12 months;
- ability to understand and sign the informed consent.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: virtual reality
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.
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The VRE will administer through the use of 3 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.
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Active Comparator: control arm
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
|
The VRE will administer through the use of 3 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of Distress
Time Frame: 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
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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
|
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evaluation of Quality of life
Time Frame: 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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Incidence of treatment-emergent adverse events
Time Frame: 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)
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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
|
|
Evaluation of Patients Report Outcomes
Time Frame: 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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Fabi Alessandra, Regina Elena Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
January 20, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
December 31, 2021
First Submitted That Met QC Criteria
February 9, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
February 10, 2022
Last Update Submitted That Met QC Criteria
February 9, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1105/18
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
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