Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer
Condition: Hot Flashes; Breast Cancer
MeSH terms: Breast Neoplasms; Hot Flashes
Study type: Interventional

Summary: 
      This study evaluates the potential of a unique artificial intelligence-virtual reality
      intervention called Bubble, to reduce the number and intensity of hot flashes and their
      accompanying psychological symptoms in women, aged 28-55, with breast cancer. A sample of 37
      women with breast cancer were selected to the study. Participants were asked to answer a
      survey before and after using Bubble. The treatment period was 24 days. The findings are
      positive and show that the use of Bubble help to reduce several psychological symptoms
      connected to hot flashes.
    

Detailed description: 
      Breast cancer is the most common cancer in women and the leading cause of death in women aged
      < 55 years . Hot flashes are experienced by about 52% of perimenopausal women. After breast
      cancer, this may increase to 70%. Hot flash is a subjective sensation of heat that is
      associated with objective signs of cutaneous vasodilatation and a subsequent drop in core
      temperature. The hot flash may be accompanied by physiological symptoms as sweating,
      flashing, palpitations, and night sweat. As well as by psychological symptoms as anxiety,
      irritability, and even panic. Hot flashes and night sweats (HF/NS) affect 65-85% of breast
      cancer survivors and are associated with sleep problems and reduced quality of life.

      It is well known that estrogen largely alleviates vasomotor symptoms, however concerns
      regarding its use in women, with or without breast cancer, has led to extensive research
      efforts to find well tolerated and efficient nonhormonal interventions. Postmenopausal women
      and breast cancer survivors experience psychological, spiritual, sleep, and cognitive
      dysfunction beyond what could be attributable to vasomotor symptoms alone. Therefore, an
      integrative intervention that can address multiple symptoms is an important patient-centric
      strategy.

      These days a growing body of research has been dedicated to mind-body interventions. These
      interventions include yoga, hypnosis, relaxation-training/paced respiration,
      mindfulness-based stress reduction (MBSR), and cognitive behavioral therapy (CBT). In
      practice, a previous study demonstrated that distressing or problematic hot flashes were
      predicted by depression, anxiety, and low self-image, but not by the frequency of the hot
      flashes. Therefore, women with the same amount of hot flashes may have different and diverse
      emotional responses to their hot flashes. This psychosocial aspect plays a role in the
      distress or can be related to the symptom as well as to the person's will to do something
      about his situation. Cognitive behavioral therapy has a long and well documented history of
      efficacy related to distress, sleep, and psychological aspects of coping with many of life's
      challenges. A study showed that a brief, mindfulness-based intervention demonstrated
      preliminary short-term efficacy in reducing stress, behavioral symptoms, and proinflammatory
      signaling in younger breast cancer survivors. Also, research indicated that relaxation
      training reduced the incidence and severity of hot flashes and the distress caused by the
      flashes in women with primary breast cancer compered to control group.

      Virtual reality (VR) is a computer technology that uses virtual reality headsets or
      multi-projected environments, sometimes in combination with physical environments or props,
      to generate realistic images, sounds and other sensations that simulate a user's physical
      presence in a virtual or imaginary environment. Today there are two main categories of VR,
      immersive and non-immersive. Immersion or presence can be regarded as a variable that can
      influence the effects on the attention of users. Full immersion is reached by a head mounted
      display, which blocks the users' view of the real world and presents patients with a view of
      a computer-generated world instead. This technology may offer subjects a safe environment.

      A review of 19 studies reporting the use of VR in therapies related to cancer patients showed
      that four out of eight studies that evaluated bio-physiological outcomes found significant
      differences in pulse rate, showing lower heart rate in the VR group compared with the
      non-treatment control group. Furthermore, all studies evaluating the efficacy of VR on
      different psychological variables found a significant improvement following treatment. In
      addition, there have been studies of virtual reality in women receiving chemotherapy, older
      women with breast cancer receiving chemotherapy, adults with breast, colon and lung cancer
      receiving chemotherapy, and older children receiving chemotherapy. Results of these
      interventions have been positive, with patients reporting to decreased psychological
      distress, perception that treatment times were shortened and a belief that treatment with
      virtual reality was better than chemotherapy alone. Importantly, patients generally did not
      report cyber sickness (i.e., nausea and discomfort that can last for hours after
      participating in VR applications) and the VR intervention was easy to implement.

      Previous findings in the field of body-mind treatments, and specifically VR as a treatment
      for women with breast cancer, have led to the current study, which aimed to evaluate the
      Bubble, a new VR-AI way of treatment specifically tailored for improving symptoms associated
      with hot flashes in female cancer patients. As previous findings in the field showed the
      advantages of VR, CBT and mindfulness as treatments for women with cancer or for women who
      suffer from hot flashes, they are not specific to hot flashes caused by cancer nor not
      combining the three methods together. In this study we are trying to understand the effect of
      CBT and mindfulness treatment when given with a VR technology. Specifically, we tried to
      explore the effect of this combined type of treatment on women who suffer from hot flashes
      caused by cancer. Furthermore, the current study tries to understand what method work for
      whom and hence we recruited younger and older women and didn't focused only on one age group.

      This pilot study evaluated the potential of a unique artificial intelligence-virtual reality
      intervention called Bubble, to reduce the number and intensity of hot flashes and their
      accompanying psychological symptoms in women, aged 28-55, with breast cancer. A repeated
      measures design was used to answer the following questions: (1) Is AI-VR an effective
      intervention for reducing hot flashes in women with breast cancer? (2) Is AI-VR intervention
      decreases the intensity and/or frequency of symptoms associated with hot flashes in women
      with breast cancer?

      Based on past research, as well as our own pilot data collected from focus groups (detailed
      in the procedure section), we hypothesized that the use of Bubble will lead to an improvement
      decrease intensity of hot flashes and the psychological symptoms connecting to them (stress,
      psychopathology level), as well as improve life and sleep quality.
    

Intervention name(s): Bubble: A New VR-AI Way of Treatment for Hot Flashes
Intervention type(s): Device
Intervention description(s): Bubble Bubble is a virtual reality (VR) mobile application. Bubble offers a psychological intervention based upon cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) protocols. The bubble mobile application offers the intervention in a virtual reality (VR) coaching environment and in a winter wonderland setting called Frosty. Frosty provides both a virtual reality winter wonderland experience as well as guided meditation. The cold, winter-like experience is designed to help patients calm down and feel cooler.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment