RECRUITING

Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers

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

This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C/RT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and/or stress in patients with HNC undergoing C/RT and their caregivers.

Official Title

Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain

Quick Facts

Study Start:2025-05-09
Study Completion:2027-11-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06985784

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PATIENTS: Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * PATIENTS: ≥ 18 years
  4. * PATIENTS: Self-reported normal or corrected to normal vision and hearing
  5. * PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)
  6. * PATIENTS: Ability to read and understand English for questionnaires
  7. * PATIENTS: Scheduled to undergo C/RT for their HNC
  8. * CAREGIVERS: Documented informed consent of the participant and/or legally authorized representative
  9. * Assent, when appropriate, will be obtained per institutional guidelines
  10. * CAREGIVERS: ≥ 18 years
  11. * CAREGIVERS: Self-reported normal or corrected to normal vision and hearing
  12. * CAREGIVERS: Ability to read and understand English for questionnaires
  13. * CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
  1. * PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
  2. * PATIENTS: A direct study team member
  3. * PATIENTS: Inability to complete the surveys
  4. * PATIENTS: Serious mental illness
  5. * PATIENTS: Previous head and neck cancer treatment
  6. * PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (\> 3 months)
  7. * PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment
  8. * CAREGIVERS: An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
  9. * CAREGIVERS: A direct study team member
  10. * CAREGIVERS: Inability to complete the surveys
  11. * CAREGIVERS: Serious mental illness
  12. * CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD

Contacts and Locations

Principal Investigator

Krupal B Patel
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Krupal B Patel, PRINCIPAL_INVESTIGATOR, City of Hope Medical 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 Date2025-05-09
Study Completion Date2027-11-09

Study Record Updates

Study Start Date2025-05-09
Study Completion Date2027-11-09

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Carcinoma