Virtual Environments in Patients Receiving Treatment for Cancer

NCT ID: NCT02392728

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2020-01-20

Brief Summary

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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

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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

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Mood Disturbances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention VE

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

Group Type EXPERIMENTAL

Immersive Virtual Reality (VR)

Intervention Type 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

Intervention Type 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

Intervention GI

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

Group Type ACTIVE_COMPARATOR

Immersive Virtual Reality (VR)

Intervention Type 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

Intervention Type 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

Interventions

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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)

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cyprus

OTHER

Sponsor Role collaborator

Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andreas Charalambous

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Charalambous

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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American Medical Centre

Nicosia, , Cyprus

Site Status

Countries

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Cyprus

References

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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.

Reference Type DERIVED
PMID: 36202024 (View on PubMed)

Other Identifiers

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AC-VES-91

Identifier Type: -

Identifier Source: org_study_id

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