Mood DisturbancesVENCT02392728
Virtual Environments in Patients Receiving Treatment for Cancer
A study testing Immersive Virtual Reality (VR) and Guided Imagery in people with Mood Disturbances, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disturbances
- What is being tested?
- Immersive Virtual Reality (VR) and Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCyprus
- Study dates
- 5 Feb 2018to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients were excluded if they were receiving palliative care
- they had an impaired cognitive ability or
- they had an impaired visual ability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Virtual Environment on the Adverse Psychological Effects 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.
Read the 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.
- Conditions
- Mood Disturbances
- Being tested
- Immersive Virtual Reality (VR), Guided Imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality (VR)Behavioural
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 ImageryBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention VE | Experimental | Session of Immersive Virtual Reality (VR) and Session of Guided Imagery Receives: Behavioral: Immersive Virtual Reality (VR); Behavioral: Guided Imagery |
| Intervention GI | Active comparator | Session of Immersive Virtual Reality (VR) and Session of Guided Imagery Receives: Behavioral: Immersive Virtual Reality (VR); Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mood Disturbances as measured by the POMS
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
Measured: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Secondary outcomes (3)
Changes in Quality of Life as measured by FACT-G
FACT-G, is a self-report instrument consisting of 27-items
Measured: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Changes in Blood Pressure
Measurement of Blood Pressure
Measured: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Changes in Heart Rate
Measurement of Heart Rate
Measured: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start5 Feb 2018
- Primary completion1 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cyprus
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas Charalambous, Principal investigator, andreas.charalambous@cut.ac.cy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392728
- Sponsor's protocol ID
- AC-VES-91
- Acronym
- VE
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2015
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36202024
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
- ClinicalTrials.gov ID
- NCT02392728
- Acronym / sponsor ID
- VE / AC-VES-91
- Conditions
- Mood Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- University of Cyprus
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention VE | Experimental | Behavioral: Immersive Virtual Reality (VR), Behavioral: Guided ImagerySession of Immersive Virtual Reality (VR) and Session of Guided Imagery |
| Intervention GI | Active comparator | Behavioral: Immersive Virtual Reality (VR), Behavioral: Guided ImagerySession of Immersive Virtual Reality (VR) and Session of Guided Imagery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients were excluded if they were receiving palliative care
- they had an impaired cognitive ability or
- they had an impaired visual ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Intervention GI, Intervention VE |
| Guided ImageryPatients 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 | Behavioural | Intervention GI, Intervention VE |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Derived from this study: PubMed 36202024Ioannou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Charalambous principal investigator
andreas.charalambous@cut.ac.cy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality (VR) and Guided Imagery in people with Mood Disturbances, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.