Look of Life 2.0. Virtual Reality for Cancer Patients in Home Palliative Care

NCT04966468 | Unknown

• 1 other identifier: 542-2019-OSS-AUSLBO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Oncological disease, in addition to undermining the physical health and autonomy of the patient, is often accompanied by significant anxious and depressive symptoms that can compromise the quality of life of both patient and his/her family, hindering the adherence to treatment, the effectiveness of therapies and worsening the clinical prognosis. Several studies confirm that a large number of cancer patients experience severe levels of psychological distress, with an average prevalence of any mood disorder ranging from 29% in palliative care to 38% in oncological and hematological settings. The advanced stages of the disease are characterized by a progressive loss of functional autonomy, forcing the patient to a condition of isolation and both sensory and relational deprivation. The reduction of the occasions in which it is possible to experience positive emotions and meaningful social interactions often corresponds to an intensification of obsessive worries and thoughts, which in turn increase stress and connect to further negative emotional experiences. Thus the patient can be trapped in a vicious circle, that might increase the worsening of quality of life. In the last years, alongside traditional interventions, the effectiveness of interventions based on the use of immersive audiovisual technologies has been tested, such as the use of virtual reality (VR), which have the ability to emotionally involve the person, capture his/her attention and direct it towards positive stimuli, without particular effort to be used. Compared to 2D or 3D videos, VR gives to the user a "greater degree of presence", giving the impression of being immersed in a reality different from the real one. Unlike any other form of psychological intervention, VR does not require special training to be used and has the advantage of being used even in situations of poor mobility or attention capacity. Available literature shows how the use of VR for cancer patients is a widespread practice that can be considered an additional psychological technique. Several studies showed that VR can help in decreasing the psychophysical symptoms usually experienced by cancer patients in different settings (e.g., chemotherapy sessions, invasive medical procedures, and hospitalization). However, up to now, there are no studies in the scientific literature on the use of VR in the context of home palliative care. In this setting, it could be extremely interesting to test the effectiveness of this innovative technology, due to its growing diffusion and accessibility. The present study is aimed at assessing the effects of VR in cancer patients followed by ANT Foundation home palliative care program. The VR headset will be kept at the patients' home so that he/she can use it in moments of greatest psychophysical discomfort (e.g., pain peaks, moments of anxiety or sadness). The VR will contain both non-interactive and interactive contents, the last ones specifically developed for ANT patients.

Conditions

Oncological Patients; Virtual Reality

Keywords

Anxiety; Cancer; Depression; Digital health care; Immersive technology; Pain; Palliative care; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Change of anxiety and depression levels.

  This outcome will be measured by evaluating the scores obtained by Hospital Anxiety and Depression Scale (HADS) at day 1 (T0) and day 4 (T1). Two separate scores will be evaluated, one for anxiety and the other for depression, ranging from a minimum of 0 to a maximum of 21 points

  Day 1 and day 4

Secondary Outcomes (4)

• Change of pain experienced in the 24 hours prior to day 1 (T0) and and day 4 (T1).

  Day 1 and day 4

• Change of short-term psychophysical symptoms immediately after using the VR headset/tablet.

  Day 1, day 2, day 3 and day 4.

• To understand which type of immersive VR content is most beneficial for the home palliative care cancer patient

  Day 1, day 2, day 3 and day 4.

• To understand the average usage of the VR headset that are the most effective.

  Day 1 and day 4

Study Arms (2)

VR Group

EXPERIMENTAL

Patients will be given the VR headset with non-interactive and interactive contents at home for four days

Device: Virtual Reality

CTR group

ACTIVE COMPARATOR

Patients will be given a tablet at home for four days with relaxing non-interactive 2D videos with natural and artistic scenarios

Other: Control

Interventions

Virtual Reality DEVICE

The Lenovo Mirage Solo Headset will be kept at home by the patient for the duration of the study (4 days). The VR headset will be equipped with 10 non-interactive videos and a short interactive game. The videos and the game are characterized by relaxing scenarios. The game will require the active interaction of the patient. At the end of the observational period, the investigator will download the usage data to detect information about the patient's use. Before and after each use of the VR headset, the patient will be asked to fulfil the Edmonton Symptom Assessment Scale (ESAS). On T0, the patient will be asked to wear a wearable device, the Empatica E4 wristband measuring physiological parameters. On day T1, the patient will return the VR headset and the wristband to the investigator and will fulfil again the HADS and BPI questionnaires.

VR Group

Control OTHER

The investigator will illustrate to the patient how to use the tablet for watching videos, suggesting using it especially in moments of psycho-physical discomfort. The tablet will be given to the patient for the duration of the study (four days). The tablet will be equipped with 10 non-interactive 2D videos characterized by relaxing settings with natural or artistic scenarios, giving a "passive" use to the patient. Before and after each use of the tablet, patient has to fullfil the ESAS digitally inserted into the tablet. Patient can answer by selecting the answer on the touchscreen. Without filling the scale, the patient will not be able to access the videos inserted in the tablet. On day T1, patient will return the tablet to the investigator and fill out the HADS and BPI questionnaires.

CTR group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to understand the objectives of the study and to sign the informed consent;

You may not qualify if:

• age 18-70 years;
• able to speak and understand the Italian language.
• cognitive disorders;
• epilepsy, dementia or other neurological disorder that could prevent the use of a VR technology;
• severe visual impairment;
• sensitivity to flashing lights;
• recent heart attack (less than 1 year);
• fixed breathing device;
• eyes or faces injuries preventing the correct use of virtual reality headset;
• unable to understand and speak the Italian language;
• unable to perform movements with the head or body to follow the 360 ° video;
• nausea or motion sickness.

Sponsors & Collaborators

• Fondazione ANT Italia ONLUS: lead
• University of Bologna: collaborator

Study Sites (1)

Fondazione ANT Italia ONLUS

Bologna, BO, 40128, Italy

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms; Depression; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vittoria Sichi

  Fondazione ANT Italia ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Ostan, PhD

CONTACT

+39 3487900191; rita.ostan@ant.it

Andrea Giannelli

CONTACT

+39 3896458617; andrea.giannelli@ant.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, Psychoterapist

Model Details: The proposed investigation is a randomized, controlled, non-profit, single-center exploratory interventional study without drugs.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 19, 2021
• Study Start: December 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)