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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03568 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24530 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM A: Participants receive 3D mindfulness VR headset consisting of 6 resilience skills training sessions over 30 minutes three times a week (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.
ARM B: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (3D mindfulness VR headset) | Experimental | 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. |
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| Arm B (2D non-immersive VR headset) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate (Feasibility) | Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics. | Up to 11 weeks |
| Retention rate (Feasibility) | Will be considered feasible if ≥ 70% of patients are retained. Will be assessed using summary statistics. | Up to 11 weeks |
| Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility) | Will be considered feasible if ≥ 50% of patients use the 3D mindfulness VR intervention. Will be assessed using summary statistics. | Up to 11 weeks |
| Completion of electronic patient reported outcomes (ePRO) (Feasibility) | Will be considered feasible if ≥ 70% ePRO assessments are completed. Will be assessed using summary statistics. | Up to 11 weeks |
| Acceptability of 3D mindfulness VR intervention | 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. | Up to 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preferences for VR based interventions | Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire. | Up to 30 days after treatment completion |
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Inclusion Criteria:
PATIENTS: Documented informed consent of the participant and/or legally authorized representative
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krupal Patel | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Medical Device Usage and Evaluation | Other | Wear a Fitbit |
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| Questionnaire Administration | Other | Ancillary studies |
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| Virtual Technology Intervention | Other | Receive 3D mindfulness VR headset |
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| Virtual Technology Intervention | Other | Receive 2D non-immersive VR headset |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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