Virtual Environments in Patients Receiving Treatment for Cancer

NCT02392728 | Completed DMC

• 1 other identifier: AC-VES-91
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disturbances

Outcome Measures

Primary Outcomes (1)

• 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

  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

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

• Changes in Blood Pressure

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

• Changes in Heart Rate

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

Study Arms (2)

Intervention VE

EXPERIMENTAL

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

Behavioral: Immersive Virtual Reality (VR); Behavioral: Guided Imagery

Intervention GI

ACTIVE COMPARATOR

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

Behavioral: Immersive Virtual Reality (VR); Behavioral: Guided Imagery

Interventions

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)

Intervention GI; Intervention VE

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

Intervention GI; Intervention VE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients were excluded if they were receiving palliative care
• they had an impaired cognitive ability or
• they had an impaired visual ability

Sponsors & Collaborators

• Cyprus University of Technology: lead
• University of Cyprus: collaborator

Study Sites (1)

American Medical Centre

Nicosia, 2047, Cyprus

Location

Related Publications (1)

• 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.

  PMID: 36202024 DERIVED

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andreas Charalambous

  andreas.charalambous@cut.ac.cy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 19, 2015
• Study Start: February 5, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 20, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

CY (1)