Status:

COMPLETED

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

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Breast Cancer

Eligibility:

All Genders

Phase:

NA

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 fi...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2021

    Estimated Enrollment :

    44 Patients enrolled

    Trial Details

    Trial ID

    NCT05234996

    Start Date

    April 1 2019

    End Date

    April 1 2021

    Last Update

    February 10 2022

    Active Locations (1)

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    alessandra Fabi

    Roma, Italy, 00164

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