Clinical trial NCT04414033: Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer
Official title: Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Breast Cancer
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: Hematology and Oncology Specialists
First posted: 2020-06-04
Enrollment: 37
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Females between the ages of 18 and 60
* Having an existing diagnosis of breast or ovarian cancer
* Receiving standard-of-care chemotherapy, endocrine therapy or estrogen blocking anti-cancer treatment
* The woman reported experiencing hot flashes at least once per day for a duration of at least 7 days prior to the beginning of the study and hot flashes for at least 30 days prior to the beginning of the study
* No chronic migraine headaches, seizure disorders, serious vestibular disorders, or pathological vertigo
* No serious psychiatric disorders
* Not pregnant
* No current substance abuse
* Not participating in other forms of therapy
* Not using medical marijuana.

Exclusion Criteria:

\* women aged 28-55 with breast cancer suffering from hot flashes

Primary outcomes:
measure: Demographic and background (disease & treatment-elated) information
timeFrame: Through study completion, an average of 1 month
measure: HFRDIS, The Hot Flash Related Daily Interference Scale
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: HFRDIS, The Hot Flash Related Daily Interference Scale
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: HFRS, The Hot Flash Rating Scale
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: HFRS, The Hot Flash Rating Scale
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: PSS, The Perceived Stress Scale
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: PSS, The Perceived Stress Scale
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: K10, The Kessler Psychological Distress Scale
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: K10, The Kessler Psychological Distress Scale
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: B-IPQ, The Brief Illness Perception Questionnaire
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: B-IPQ, The Brief Illness Perception Questionnaire
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: PSQI, The Pittsburgh Sleep Quality Index
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: PSQI, The Pittsburgh Sleep Quality Index
timeFrame: Through study completion, an average of 1 month, after the manipulation
measure: WHOQOL-BREF, The World Health Organization Quality of Life Scale
timeFrame: Through study completion, an average of 1 month, before the manipulation
measure: WHOQOL-BREF, The World Health Organization Quality of Life Scale
timeFrame: Through study completion, an average of 1 month, after the manipulation
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar Ilan University
Study officials:
References: