Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers
Head and Neck Carcinoma
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 40 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Recruitment rate (Feasibility)
Plazo: Up to 11 weeks
Will be considered feasible if ≥ 50% of patients agree to participate. Will be assessed using summary statistics.
Retention rate (Feasibility)
Plazo: 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)
Plazo: 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)
Plazo: 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
Plazo: 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.
Medidas secundarias
Preferences for VR based interventions
Plazo: Up to 30 days after treatment completion
Will be assessed by interviews to obtain feedback. Descriptive statistics to summarize satisfaction questionnaire.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
City of Hope Medical CenterDuarte, California, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- City of Hope Medical Center
- Inicio del estudio
- 25 jun 2025 Real
- Finalización primaria
- 9 nov 2027 Estimado
- Finalización del estudio
- 9 nov 2027 Estimado
- Primera publicación
- 22 may 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026