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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234996
• Other study ID #: 1105/18
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 1, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 3 Virtual Reality headset (VR Headset),
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.

Locations

Country	Name	City	State
Italy	alessandra Fabi	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of Distress	Distress is evaluate with HAds questionnaire	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
Primary	evaluation of Quality of life	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	Evaluation of Incidence of treatment-emergent adverse events	this incidence in evaluate and classified with the Common Terminology Criteria for Adverse Events (CTCAE 5.0)	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	Evaluation of Patients Report Outcomes	This outcomes is evaluated with PROs	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