Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate (Feasibility)
研究概览
简要总结
This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C/RT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and/or stress in patients with HNC undergoing C/RT and their caregivers.
详细描述
PRIMARY OBJECTIVE:
I. Feasibility and acceptability of 3D mindfulness VR- vs 2D in HNC patients undergoing C/RT.
SECONDARY OBJECTIVES:
I. Assess patient- and caregiver-preference for 3D VR and non-immersive interventions.
II. Preliminary efficacy in reduction in depressive symptoms, anxiety and pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS: Documented informed consent of the participant and/or legally authorized representative
- •Assent, when appropriate, will be obtained per institutional guidelines
- •PATIENTS: ≥ 18 years
- •PATIENTS: Self-reported normal or corrected to normal vision and hearing
- •PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)
- •PATIENTS: Ability to read and understand English for questionnaires
- •PATIENTS: Scheduled to undergo C/RT for their HNC
- •CAREGIVERS: Documented informed consent of the participant and/or legally authorized representative
- •Assent, when appropriate, will be obtained per institutional guidelines
- •CAREGIVERS: ≥ 18 years
- •CAREGIVERS: Self-reported normal or corrected to normal vision and hearing
- •CAREGIVERS: Ability to read and understand English for questionnaires
- •CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
排除标准
- •PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
- •PATIENTS: A direct study team member
- •PATIENTS: Inability to complete the surveys
- •PATIENTS: Serious mental illness
- •PATIENTS: Previous head and neck cancer treatment
- •PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (> 3 months)
- •PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment
- •CAREGIVERS: An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
- •CAREGIVERS: A direct study team member
- •CAREGIVERS: Inability to complete the surveys
- •CAREGIVERS: Serious mental illness
- •CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD
研究组 & 干预措施
Arm A (3D mindfulness VR headset)
Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Interview (Other)
Arm A (3D mindfulness VR headset)
Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm A (3D mindfulness VR headset)
Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Questionnaire Administration (Other)
Arm A (3D mindfulness VR headset)
Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Virtual Technology Intervention (Other)
Arm B (2D non-immersive VR headset)
Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Interview (Other)
Arm B (2D non-immersive VR headset)
Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm B (2D non-immersive VR headset)
Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Questionnaire Administration (Other)
Arm B (2D non-immersive VR headset)
Participants receive 2D non-immersive VR headset consisting of 2 scenarios - walk in the nature and beach TIW for 6-7 weeks then weekly for 4 weeks. Participants also wear a Fitbit activity tracker to monitor heart rate, sleep and activity throughout the study.
干预措施: Virtual Technology Intervention (Other)
结局指标
主要结局
Recruitment rate (Feasibility)
时间窗: Up to 11 weeks
Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.
Retention rate (Feasibility)
时间窗: Up to 11 weeks
Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics.
Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)
时间窗: Up to 11 weeks
Will be considered feasible if ≥ 50% of patients use the 3D mindfulness VR intervention. Will be assessed using summary statistics.
Completion of electronic patient reported outcomes (ePRO) (Feasibility)
时间窗: Up to 11 weeks
Will be considered feasible if ≥ 70% ePRO assessments are completed. Will be assessed using summary statistics.
Acceptability of 3D mindfulness VR intervention
时间窗: Up to 11 weeks
Will be considered acceptable if ≥ 50% patients have greater than neutral satisfaction at the end of the study period. Will be assessed using summary statistics.
次要结局
- Preferences for VR based interventions(Up to 30 days after treatment completion)