Virtual Reality Software to Reduce Stress in Cancer Patients

NCT05263648 | Withdrawn

• 1 other identifier: OU-SCC-Virtual Reality
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.

Conditions

Breast Cancer; Head and Neck Cancer

Keywords

Virtual Reality; Radiation Therapy; Education; Distress; Stress

Outcome Measures

Primary Outcomes (3)

• Proportion of patients who complete 2 VR sessions

  Percentage of patients who complete 2 VR sessions will be calculated.

  Up to 3 Months

• Proportion of patients reporting ease of use for VR sessions

  Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.

  Up to 3 Months

• Proportion of overall adherence to radiation therapy

  Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.

  Up to 3 Months

Secondary Outcomes (3)

• Change in state trait anxiety scale

  Up to 3 Months

• Change in brief symptom inventory

  Up to 3 Months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)

  Up to 3 Months

Study Arms (1)

Virtual Reality Sessions

OTHER

Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment.

Other: Virtual Reality Session

Interventions

Virtual Reality Session OTHER

VR-based education sessions will be used to influence patients' perceived emotional and social distress while undergoing radiation therapy (RT). Emotional and social distress levels will be evaluated using questionnaires at baseline (prior to the first VR experience), at completion of RT, and at 30-60 days post RT.

Virtual Reality Sessions

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is accruing 10 males and 10 females (n=20) by self-identification. No other genders will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Must be able to read and speak English
• Diagnosis of breast or head and neck cancer
• Treatment plan includes radiotherapy within the next 2 months
• Signed study-specific informed consent prior to study entry

You may not qualify if:

• Previous radiation therapy treatment
• Neurologic deficits
• Visual disorder
• Neuro-psychiatric disorder
• Use of neuro-psychiatric drugs

Sponsors & Collaborators

• University of Oklahoma: lead

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Henson, MD

  Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share