Clinical trial NCT02392728: Virtual Environments in Patients Receiving Treatment for Cancer
Official title: The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disturbances
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: University of Cyprus
First posted: 2015-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Mood Disturbances as measured by the POMS
timeFrame: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Secondary outcomes:
measure: Changes in Quality of Life as measured by FACT-G
timeFrame: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
measure: Changes in Blood Pressure
timeFrame: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
measure: Changes in Heart Rate
timeFrame: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: American Medical Centre
Study officials:
affiliation: andreas.charalambous@cut.ac.cy
name: Andreas Charalambous
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ioannou A, Paikousis L, Papastavrou E, Avraamides MN, Astras G, Charalambous A. Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Eur J Oncol Nurs. 2022 Dec;61:102188. doi: 10.1016/j.ejon.2022.102188. Epub 2022 Aug 13.