Head and Neck Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuestionnaire Administration
Ancillary studies
Receive 3D mindfulness VR headset
OTHERInterview
Ancillary studies
OTHERMedical Device Usage and Evaluation
Wear a Fitbit
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate (Feasibility) | Up to 11 weeks | Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics. |
| Retention rate (Feasibility) | 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) | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preferences for VR based interventions | Up to 30 days after treatment completion | Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire. |
Countries
United States
Outcome results
None listed