跳至主要内容
临床试验/NCT04966468
NCT04966468Unknown不适用

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

Fondazione ANT Italia ONLUS2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change of anxiety and depression levels.

研究概览

简要总结

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.

详细描述

Background Many cancer patients experience severe levels of psychological distress, with a percentage varying from 10-15% to 20-40% (Mitchell et al., 2011; Shim et al., 2018). The average prevalence of mood disorders ranges from 29% in palliative care settings to 38% in cancer and hematological contexts (Jacobsen et al., 2005). In addition to the emotional distress, the advanced stages of the disease often imply a progressive loss of functional autonomy (Dong et al., 2016). This put the patient in a status of deprivation and forced isolation from relational and social aspects that were hitherto in their lives. This psychological distress naturally adds to the burden of the physical symptoms caused by the disease and/or invasive therapies, above all pain.

In the last years, technological innovation has allowed new solutions to meet old and emerging needs in the healthcare field. One of these is represented by Virtual Reality (VR), a non-invasive simulation technology that allows the user to be immersed in a multisensory experience. VR technologies can emotionally involve the patients, inducing a positive mood and allowing them to feel like a part of the virtual environment (Malloy and Milling, 2010; Pourmand et al., 2018; Ahmadpour et al., 2019). The distraction effect is recognized to be the primary principle underlying the effectiveness of VR (Schneider et al., 2004; Malloy and Milling, 2010; Wiederhold et al., 2014; Bani Mohammad and Ahmad, 2019), as it is capable of diverting patient's attention from his or her current clinical condition. Natural contents have been shown to induce relaxation and restore work productivity, based on the Attention Restoration Theory (Kaplan, 1995; Berto, 2005; Anderson et al., 2017). Moreover, water scenes with views and sound seem to be more appreciated than scenes without water (White et al., 2010; Anderson et al., 2017). Additionally, interactive contents could be even more effective in their distraction-based effect than contents that only require passive observation (Wiederhold and Wiederhold, 2007; Shahrbanian et al., 2012; Wender et al., 2019). VR-based interventions are a convenient solution, as they do not require complicated training to be used and can be employed in case of low mobility conditions.

VR has been used as an adjuvant treatment in various clinical conditions to relieve pain, anxiety, and depression (Dascal et al., 2017; Fodor et al., 2018), during invasive procedures (Hoffman et al., 2011; Shetty et al., 2019; Brown and Foronda, 2020), for chronic pain management (Wiederhold et al., 2014; Pekyavas and Ergun, 2017) and in rehabilitation settings (Shahrbanian et al., 2012; Lee et al., 2015). It has been extensively employed in promoting cancer patients' psychological well-being (Chirico et al., 2016; Zeng et al., 2019; Ioannou et al., 2020). Previous studies assessed the effects of VR in relieving cancer-related symptomatology mainly in clinical settings (Li et al., 2011; Baños et al., 2013; Mosadeghi et al., 2016; Bani Mohammad and Ahmad, 2019), alleviating anxiety and improving mood states. Studies in palliative care (PC) have proven the acceptability of VR interventions (Oyama, 1997; Brungardt et al., 2020; Weingarten et al., 2020) and their effect in reducing short-term symptoms (i.e., pain, drowsiness, lack of appetite, shortness of breath, depression, anxiety, and well-being) (Niki et al., 2019; Johnson et al., 2020).

The evidence about the use of VR in a home PC program is still insufficient. To fill this gap, the National Tumor Assistance Foundation (ANT), a non-profit organization working in Italy in the field of home PC and pain management, conducted a pilot study to test the feasibility of VR interventions for cancer patients assisted at home (Varani et al., 2018). This was the first attempt to introduce VR interventions in home-PC settings, obtaining promising results: most participants (73%) declared that they would be willing to keep a VR headset at home; patients showed a 20% decrease in anxiety and depression and a significant reduction of perceived pain and fatigue symptoms. As a further outcome, ANT collected patients' preferences as the output of a focus group and semi-structured interviews: all patients declared to prefer natural and relaxing scenarios, 36% expressed a preference for interactive videos, while 33% wanted to see videos as simple observers (Sichi et al., 2019).

After these encouraging results, ANT introduced the VR headset with interactive and non-interactive contents in its home-care practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • able to understand the objectives of the study and to sign the informed consent;
  • patient in ANT assistance, and not excluded according to the exclusion criteria listed below;
  • age 18-70 years;
  • able to speak and understand the Italian language.

排除标准

  • 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.

结局指标

主要结局

Change of anxiety and depression levels.

时间窗: Day 1 and day 4

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

次要结局

  • To understand the average usage of the VR headset that are the most effective.(Day 1 and day 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vittoria Sichi

Psychologist, Psychoterapist

Fondazione ANT Italia ONLUS

研究点 (2)

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