RECRUITING

Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain. Participants will: * Be randomly assigned to one of two available groups (virtual reality or standard of care) * Participations will only be during one chemotherapy session. * Those assigned to virtual reality: * The research team will provide a virtual reality * The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns. * Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes * Those assigned to the standard of care: * The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.

Official Title

Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer

Quick Facts

Study Start:2024-11-05
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06446115

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Biopsy proven diagnosis of Cancer (any stage or type).
  3. * Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
  4. * Must have the ability to understand and the willingness to sign a written informed consent document
  5. * Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
  6. * Ability to read and write in English or Spanish.
  1. * Age \<18 years.
  2. * No prior history of Cancer.
  3. * Prior medical history of severe motion sickness.
  4. * Prior medical history of seizures
  5. * Pregnancy.
  6. * Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center

Contacts and Locations

Study Contact

Zeina Nahleh, MD FACP
CONTACT
(954) 659-5840
nahlehz@ccf.org

Principal Investigator

Zeina Nahleh, MD FACP
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida, Maroone Cancer Center

Study Locations (Sites)

Cleveland Clinic Florida, Maroone Cancer Center
Weston, Florida, 33331
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Zeina Nahleh, MD FACP, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Florida, Maroone Cancer Center

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 Registration Dates

Study Start Date2024-11-05
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-11-05
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • Chemotherapy

Additional Relevant MeSH Terms

  • Malignant Neoplasm
  • Cancer