Virtual Environments in Patients Receiving Treatment for Cancer

Not Applicable

Completed

• Conditions: Mood Disturbances
• Interventions: Behavioral: Immersive Virtual Reality (VR); Behavioral: Guided Imagery

• Registration Number: NCT02392728
• Lead Sponsor: Cyprus University of Technology

Brief Summary

The mood disturbances that lung cancer patients experience during and after chemotherapy have a debilitating effect on their quality of life. The goal of the proposed project is to develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to combat the adverse psychological/emotional consequences of receiving treatment for cancer. Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.

Detailed Description

Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.

Study Timeline

• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Study Start: 2018-02-05
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients will be included if they had a histopathological diagnosis of cancer (different types are allowed)
• were 18 years or older, on active treatment and were receiving care at the hospital as inpatients
• Eligible participants will need to be able to speak and understand Greek and they had given written informed consent
• Participants should also have a score of >60 on the POMS total mood disturbance scale, a >50 on the Karnofsky Performance Scale Index
• a mean of >50 on the Attentional Function Index (AFI)

Exclusion Criteria

• Patients were excluded if they were receiving palliative care
• they had an impaired cognitive ability or
• they had an impaired visual ability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention VE	Immersive Virtual Reality (VR)	Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
Intervention GI	Guided Imagery	Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
Intervention VE	Guided Imagery	Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
Intervention GI	Immersive Virtual Reality (VR)	Session of Immersive Virtual Reality (VR) and Session of Guided Imagery

Primary Outcome Measures

Name	Time	Method
Changes in Mood Disturbances as measured by the POMS	Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days	The POMS total mood disturbance comprises subscales that evaluate anxiety, depression, anger, vigor, fatigue, and confusion. The possible range of scores for the TMDS is -40 through 192 with higher scores indicating greater mood. Lower scores indicate an improvement in mood

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life as measured by FACT-G	Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days	FACT-G, is a self-report instrument consisting of 27-items
Changes in Heart Rate	Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days	Measurement of Heart Rate
Changes in Blood Pressure	Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days	Measurement of Blood Pressure

Trial Locations

Locations (1)

American Medical Centre; 🇨🇾 Nicosia, Cyprus