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

NCT ID: NCT05234996

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-04-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

3 Virtual Reality headset (VR Headset),

Intervention Type: DEVICE

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.

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

Group Type: ACTIVE_COMPARATOR

3 Virtual Reality headset (VR Headset),

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

FABI ALESSANDRA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabi Alessandra

Role: STUDY_DIRECTOR

Regina Elena Cancer Institute

Locations

alessandra Fabi

Roma, , Italy

Countries

Italy

References

Fabi A, Fotia L, Giuseppini F, Gaeta A, Falcicchio C, Giuliani G, Savarese A, Taraborelli E, Rossi V, Malaguti P, Giannarelli D, Pugliese P, Cognetti F. The immersive experience of virtual reality during chemotherapy in patients with early breast and ovarian cancers: The patient's dream study. Front Oncol. 2022 Sep 30;12:960387. doi: 10.3389/fonc.2022.960387. eCollection 2022.

Reference Type: DERIVED

PMID: 36249001 (View on PubMed)

Other Identifiers

1105/18

Identifier Type: -

Identifier Source: org_study_id