RecruitingNCT06985784ClinicalTrials.gov record

Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers

Head and Neck Carcinoma

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

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.

Other: Interview · Other: Medical Device Usage and Evaluation · Other: Questionnaire Administration · Other: Virtual Technology Intervention

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.

Other: Interview · Other: Medical Device Usage and Evaluation · Other: Questionnaire Administration · Other: Virtual Technology Intervention

Interview OTHER

Ancillary studies

Medical Device Usage and Evaluation OTHER

Wear a Fitbit

Questionnaire Administration OTHER

Ancillary studies

Virtual Technology Intervention OTHER

Receive 3D mindfulness VR headset

Virtual Technology Intervention OTHER

Receive 2D non-immersive VR headset

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