VE: Virtual Environments in Patients Receiving Treatment for Cancer

Sponsor
Cyprus University of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT02392728
Collaborator
University of Cyprus (Other)
50
1
2
23.5
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Immersive Virtual Reality (VR)
  • Behavioral: Guided Imagery
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
Actual Study Start Date :
Feb 5, 2018
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention VE

Session of Immersive Virtual Reality (VR) and Session of Guided Imagery

Behavioral: Immersive Virtual Reality (VR)
Patients in this group will experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller. Following a resting period the patients will then experience the guided imagery session (e.g. visual images of pleasant scenery)

Behavioral: Guided Imagery
Patients in this group will experience the guided imagery (e.g. visual images of pleasant scenery). Following a resting period the patients will then experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller

Active Comparator: Intervention GI

Session of Immersive Virtual Reality (VR) and Session of Guided Imagery

Behavioral: Immersive Virtual Reality (VR)
Patients in this group will experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller. Following a resting period the patients will then experience the guided imagery session (e.g. visual images of pleasant scenery)

Behavioral: Guided Imagery
Patients in this group will experience the guided imagery (e.g. visual images of pleasant scenery). Following a resting period the patients will then experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 American Medical Centre Nicosia Cyprus 2047

Sponsors and Collaborators

  • Cyprus University of Technology
  • University of Cyprus

Investigators

  • Principal Investigator: Andreas Charalambous, andreas.charalambous@cut.ac.cy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Andreas Charalambous, Assistant Professor, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT02392728
Other Study ID Numbers:
  • AC-VES-91
First Posted:
Mar 19, 2015
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 20, 2020