Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer

NCT04414033 | Completed

• 1 other identifier: 22012020
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Breast Cancer

Outcome Measures

Primary Outcomes (15)

• Demographic and background (disease & treatment-elated) information

  A form was used to assess demographic information, including birth date, race, education, marital status, employment status, and household income. Women also were asked to record their height and weight, which was used to calculate body mass index. Routine information regarding date of diagnosis, stage of disease, and types and dates of cancer treatments was obtained from medical records

  Through study completion, an average of 1 month

• HFRDIS, The Hot Flash Related Daily Interference Scale

  The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.

  Through study completion, an average of 1 month, before the manipulation

• HFRDIS, The Hot Flash Related Daily Interference Scale

  The Hot Flash Related Daily Interference Scale (HFRDIS;Carpenter, 2001) is a 10-item scale measuring the degree to which hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to the impact of hot flashes. Participants rate the degree to which hot flashes have interfered with each item during the previous week using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.

  Through study completion, an average of 1 month, after the manipulation

• HFRS, The Hot Flash Rating Scale

  measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.

  Through study completion, an average of 1 month, before the manipulation

• HFRS, The Hot Flash Rating Scale

  measures the frequency and intensity of hot flashes and night sweats per day and per week. It also estimates chronicity and average duration of the hot flashes, as well as provides rating on three separate ten-point scales (1/10 being the least and 10/10 being the most) for the amount of distress, the extent to which HFs interfered with daily life and the degree to which HFs were a problem in patients' lives. A higher score indicates more HF per day.

  Through study completion, an average of 1 month, after the manipulation

• PSS, The Perceived Stress Scale

  a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.

  Through study completion, an average of 1 month, before the manipulation

• PSS, The Perceived Stress Scale

  a self-reported questionnaire that was designed to measure the degree to which situations in one's life over the past week are appraised as unpredictable, uncontrollable and overwhelming. It posits that people appraise potentially-threatening or challenging events in relation to their available coping resources. Items are rated on a Likert scale ranging from 0 (never) to 4 (very often). A higher score indicates a greater degree of perceived stress.

  Through study completion, an average of 1 month, after the manipulation

• K10, The Kessler Psychological Distress Scale

  10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.

  Through study completion, an average of 1 month, before the manipulation

• K10, The Kessler Psychological Distress Scale

  10-item measure of psychological distress in the past month, which reliably predicts the presence of a current depressive or anxiety disorder at a cut-off score of 17. The K10 is a 10-item questionnaire rated on a five-point Likert-type scale (from "none of the time" = 1 to "all of the time" = 5). A higher score indicates a greater degree of distress.

  Through study completion, an average of 1 month, after the manipulation

• B-IPQ, The Brief Illness Perception Questionnaire

  is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.

  Through study completion, an average of 1 month, before the manipulation

• B-IPQ, The Brief Illness Perception Questionnaire

  is designed to provide simple and rapid assessment of illness perceptions, using single items on a scale from 1-10 to assess each item including; perceived consequences, timeline (acute vs chronic), amount of perceived personal control, treatment control, identity (symptoms), concern about the illness, coherence of the illness and emotional representation of the illness.

  Through study completion, an average of 1 month, after the manipulation

• PSQI, The Pittsburgh Sleep Quality Index

  a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.

  Through study completion, an average of 1 month, before the manipulation

• PSQI, The Pittsburgh Sleep Quality Index

  a retrospective self-report questionnaire that measures sleep quality over the previous month. Seven clinically derived domains of sleep difficulties (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) are assessed. The PSQI global score allowed discriminating between healthy controls and patients, and between groups of patients affected by different pathologies. Results also indicated that the best cut-off score (differentiating "good" from "bad" sleepers) is 5.

  Through study completion, an average of 1 month, after the manipulation

• WHOQOL-BREF, The World Health Organization Quality of Life Scale

  assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).

  Through study completion, an average of 1 month, before the manipulation

• WHOQOL-BREF, The World Health Organization Quality of Life Scale

  assesses individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The WHOQOL-BREF is a 26-item version of the WHOQOL-100 scale, and as the WHOQOL-100 it includes four domains: physical, psychological, social and environmental QOL and 5-point response scales (5,Very satisfied-1,Very dissatisfied;1,Not at all-5,Extremely; 1,Not at all-5,Completely; and 1,Never-5,Always) and Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).

  Through study completion, an average of 1 month, after the manipulation

Study Arms (1)

research group

EXPERIMENTAL

Device: Bubble: A New VR-AI Way of Treatment for Hot Flashes

Interventions

Bubble: A New VR-AI Way of Treatment for Hot Flashes DEVICE

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.

research group

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• Hematology and Oncology Specialists: collaborator

Study Sites (1)

Bar Ilan University

Ramat Gan, Israel

Location

Related Links

• Andrews, G., \& Slade, T. (2001). Interpreting scores on the Kessler Psychological Distress Scale (K10). Australian and New Zealand Journal of Public Health, 25(6), 494-497.
• Blumel, J. E., Castelo-Branco, C., Binfa, L., Gramegna, G., Tacla, X., Aracena, B., … Sanjuan, A. (2000). Quality of life after the menopause: A population study. Maturitas, 34(1), 17-23.
• Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., \& Kupfer, D. J. (1989). The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213
• Fenlon, D. R., Corner, J. L., \& Haviland, J. S. (2008). A Randomized Controlled Trial of Relaxation Training to Reduce Hot Flashes in Women with Primary Breast Cancer. Journal of Pain and Symptom Management, 35(4), 397-405
• Hardy, C. (2017). The Hot Flash Related Daily Interference Scale: Cutoffs, minimally important differences, and a revised short version. Menopause, 24(8), 869-870.
• Kadakia, K. C., Loprinzi, C. L., \& Barton, D. L. (2012). Hot flashes: The ongoing search for effective interventions. Menopause: The Journal of The North American Menopause Society, 19(7), 719-721.
• Lee, E.-H. (2012). Review of the Psychometric Evidence of the Perceived Stress Scale. Asian Nursing Research, 6(4), 121-127.
• Nilsson, S., Finnström, B., Kokinsky, E., \& Enskär, K. (2009). The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. European Journal of Oncology Nursing, 13(2), 102-109
• Schneider, Susan M., Ellis, M., Coombs, W. T., Shonkwiler, E. L., \& Folsom, L. C. (2003). Virtual Reality Intervention for Older Women with Breast Cancer. CyberPsychology \& Behavior, 6(3), 301-307.
• Schneider, Susan M., \& Hood, L. E. (2007). Virtual Reality: A Distraction Intervention for Chemotherapy. Oncology Nursing Forum, 34(1), 39-46
• Schneider, Susan M., Prince-Paul, M., JoAllen, M., Silverman, P., \& Talaba, D. (2004). Virtual Reality as a Distraction Intervention for Women Receiving Chemotherapy. Oncology Nursing Forum, 31(1), 81-88.
• Skevington, S. M., Lotfy, M., \& O'Connell, K. A. (2004). The World Health Organization's WHOQOL-BREF quality of life assessment: Psychometric properties and results of the international field trial.
• Stearns, V., Ullmer, L., Lopez, J. F., Smith, Y., Isaacs, C., \& Hayes, D. F. (2002). Hot flushes. The Lancet, 360(9348), 1851-1861
• Tatrow, K., \& Montgomery, G. H. (2006). Cognitive Behavioral Therapy Techniques for Distress and Pain in Breast Cancer Patients: A Meta-Analysis. Journal of Behavioral Medicine, 29(1), 17-27
• The World Health Organization quality of life assessment (WHOQOL): Position paper from the World Health Organization. (1995). Social Science \& Medicine, 41(10), 1403-1409.

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer and head of the Trauma and Stress Research Lab at Bar-Ilan University's Department of Psychology

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 4, 2020
• Study Start: February 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

IL (1)