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OpenTrials
Completed

NCT Number: NCT02392728

Virtual Environments in Patients Receiving Treatment for Cancer

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Medical Centre

Nicosia, 2047, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immersive Virtual Reality (VR)

Behavioral

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)

GUIDED IMAGERY

Behavioral

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

Primary outcomes

  1. Changes in Mood Disturbances as measured by the POMS

    Time frame: 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 outcomes

  1. Changes in Quality of Life as measured by FACT-G

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days

    Measurement of Heart Rate

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Collaborators

  • University of Cyprus

Registry information

Official study title

The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer

Acronym: VE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2015
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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