Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- VR effect on perceived fatigue
研究概览
简要总结
We propose an innovative approach to symptom management in cancer patients following cancer treatments, utilizing a Multimodal Integrative Therapy (MIT) delivered via Virtual Reality (VR) program, authorized by the US Food and Drug Administration for in-home use. Our primary goal is to generate pilot data on the effects of MIT-VR program on pain, fatigue, sleep, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.
详细描述
All of the study procedures will be completed over ten weeks, during which participants will complete one in-person enrollment visit per intervention and check in-phone calls as needed during the duration of each intervention. Participants will be randomly assigned in a 1:1 fashion to one of two different interventions first: virtual reality or Mp4 audio. At home, participants will engage in their assigned intervention 5x throughout the week for five weeks using the provided device and fill out required questionnaires. Once participants complete their first intervention, they will begin the second intervention.
In the virtual reality intervention, participants will complete the scheduled educational module five times in each of the five weeks. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes. Similarly, in the audio intervention, participants will complete the scheduled module 5 times a week in each of the five weeks of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes.
The first visit is an enrollment visit. For the enrollment visit, the participant will first complete a battery of baseline surveys. They will also receive instructions about the intervention and go through the first module of the intervention to which he or she is assigned. A member of the research team will stay with the participant while the participant completes the module to ensure the proper functioning of the device and will answer any questions that may arise. The team member will also guide the participant on how to use the device. During the five weeks of the intervention, each participant can have check-in phone calls as needed. During these check-ins, we will address any questions and issues that arise for participants to encourage compliance. Participants will return the devices after each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study coordinator will not be blinded as they will need to administer consents and interact with participants. However, lead study investigators and outcomes assessors will be blinded to treatment group.
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-88
- •Cancer diagnosis (histology verified)
- •Had surgical intervention, completed chemotherapy or radiation for therapeutic purposes
- •>3 months since last cancer treatment, but participants currently undergoing endocrine or immunotherapy treatments are permissible
- •Documented symptoms of cancer or cancer therapy including at least one of the following: pain, anxiety, sleep difficulty, fatigue, neuropathy
- •English speaker (written and spoken)
排除标准
- •Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years
- •Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
- •Diagnosis and treatment of chronic pain, neuropathy, fatigue, sleep or anxiety disorder prior to cancer diagnosis
- •Current Hospice or palliative care only recipients
- •Color-blindness
- •Impaired or uncorrected hearing
- •Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
- •Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
- •Known history of severe motion sickness
- •Pregnancy or breast feeding
研究组 & 干预措施
Virtual reality arm
In the virtual reality intervention, participants will complete the scheduled educational module five times in the week of the intervention. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes.
干预措施: Relievrx (Device)
Audio Mp4 arm
In the audio intervention, participants will complete the scheduled module 5 times a week of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes.
干预措施: Audio Mp4 (Other)
结局指标
主要结局
VR effect on perceived fatigue
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
VR effect on perceived anxiety
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Audio effect on perceived anxiety
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Audio effect on perceived fatigue
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
VR effect on perceived pain
时间窗: Baseline to end of intervention (4 weeks)
During daily intervention sessions (VR), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine VR's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
Difference in effect of VR vs audio MP4 intervention on pain
时间窗: Baseline to end of intervention (4 weeks)
Scores from the daily pre and post pain surveys of each group with be compared to examine whether audio or VR had a greater impact on pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
Difference in effect of VR vs audio MP4 intervention on anxiety
时间窗: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS anxiety surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.
Difference in effect of VR vs audio MP4 intervention on depression
时间窗: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS depression surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Audio effect on perceived pain
时间窗: Baseline to end of intervention (4 weeks)
During daily intervention sessions (audio), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine audio MP4's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.
VR effect on perceived depression
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Audio effect on perceived depression
时间窗: Baseline to end of intervention (4 weeks)
Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.
Difference in effect of VR vs audio MP4 intervention on fatigue
时间窗: Baseline to end of intervention (4 weeks)
Scores from the baseline and weekly PROMIS fatigue surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.
次要结局
未报告次要终点