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

NCT05234996 | Completed

• 1 other identifier: 1105/18
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; virtual reality; supportive care

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

virtual reality

ACTIVE COMPARATOR

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.

Device: 3 Virtual Reality headset (VR Headset),

control arm

ACTIVE COMPARATOR

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

Device: 3 Virtual Reality headset (VR Headset),

Interventions

3 Virtual Reality headset (VR Headset), 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; virtual reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

alessandra Fabi

Roma, 00164, Italy

Location

Related Publications (1)

• 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.

  PMID: 36249001 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fabi Alessandra

  Regina Elena Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: February 10, 2022
• Study Start: April 1, 2019
• Primary Completion: January 20, 2021
• Study Completion: April 1, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)