Virtual Environments in Patients Receiving Treatment for Cancer (VE)
17 juillet 2020 mis à jour par: Dr. Andreas Charalambous, Cyprus University of Technology
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Nicosia, Chypre, 2047
- American Medical Centre
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention VE
Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
|
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)
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
|
|
Comparateur actif: Intervention GI
Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
|
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)
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Mood Disturbances as measured by the POMS
Délai: 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
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Quality of Life as measured by FACT-G
Délai: 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
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
|
Changes in Blood Pressure
Délai: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Measurement of 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
Délai: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Measurement of Heart Rate
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Andreas Charalambous, andreas.charalambous@cut.ac.cy
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 février 2018
Achèvement primaire (Réel)
1 janvier 2020
Achèvement de l'étude (Réel)
20 janvier 2020
Dates d'inscription aux études
Première soumission
6 mars 2015
Première soumission répondant aux critères de contrôle qualité
13 mars 2015
Première publication (Estimation)
19 mars 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2020
Dernière vérification
1 juillet 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- AC-VES-91
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .