Clinical trial NCT04544618: Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients
Official title: Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Keywords: Preoperative anxiety
Cancer
Virtual reality
Feasibility
Pilot study
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will employ a single-blind randomized design (1:1 randomization; stratified according to surgery type \[with vs. without reconstruction\] and whether or not neoadjuvant chemotherapy was received; stratification will designate equal proportions of participants with these characteristics across each of the two study groups).
Primary purpose: OTHER

Brief summary: This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce anxiety/distress in cancer surgery patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, and the inclusion of a treatment as usual group, and effects of the intervention on symptoms of anxiety/distress. Results of this study will inform the design of an upcoming larger-scale RCT to assess the efficacy of this intervention


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Can speak and read English
* Has a cancer diagnosis
* Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)

Exclusion Criteria:

* Those who do not meet any inclusion criteria
* Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
* Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)

Primary outcomes:
measure: Self-reported impressions of the virtual reality operating room simulation
timeFrame: Baseline
measure: Self-reported impressions of the virtual reality operating room simulation
timeFrame: 5 days
Secondary outcomes:
measure: NCCN Distress Thermometer
timeFrame: Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
measure: NCCN Anxiety Thermometer
timeFrame: Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
measure: iGroup Presence Questionnaire
timeFrame: Immediately after the intervention
measure: Preoperative Intrusive Thoughts Inventory (PITI)
timeFrame: Baseline and up to 2 weeks after baseline on day of scheduled surgery
measure: Amsterdam Preoperative Anxiety Information Scale (APAIS)
timeFrame: Baseline and up to 2 weeks after baseline on day of scheduled surgery
Other outcomes:
measure: PROMIS emotional distress- anxiety
timeFrame: Baseline, 5 days, and 30 days
measure: PROMIS emotional distress- depression
timeFrame: Baseline, 5 days, and 30 days
measure: PROMIS global health
timeFrame: Baseline, 5 days, and 30 days
measure: PROMIS fatigue
timeFrame: Baseline, 5 days, and 30 days
measure: PROMIS emotional support
timeFrame: Baseline, 5 days, and 30 days
measure: PROMIS pain intensity
timeFrame: 5 days and 30 days
measure: Peritraumatic Distress Inventory (PDI)
timeFrame: Baseline and 5 days
measure: Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
timeFrame: Baseline and 30 days
measure: Brief Resilient Coping Scale (BRCS)
timeFrame: Baseline, 5 days, and 30 days
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jordana Sommer, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Renée El-Gabalawy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Kristin Reynolds, PhD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Pamela Hebbard, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Natalie Mota, PhD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Alan Mutch, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Thomas Mutter, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Rakesh Arora, MD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Jessica Maples-Keller, PhD
role: STUDY_DIRECTOR
References: