Peer Support Program for Improving Quality of Life Among Head and Neck Patients, Connecting Through Cancer Trial
13 de julio de 2026 actualizado por: Ryan Li, MD, OHSU Knight Cancer Institute
Connecting Through Cancer: Feasibility of a Peer Support Program for Head and Neck Patients
This clinical trial tests whether a peer support program is feasible for head and neck cancer patients.
Social support at the time of diagnosis has been shown to improve head and neck cancer quality of life before and after treatment.
However, not all patients have a strong social support system.
Recent research has shown that peer support programs have the potential to address unmet social support needs among cancer patients.
These programs involve cancer survivors (peer mentors) providing emotional and informational support to cancer patients (mentees) earlier in their disease course.
Peer support programs may also reduce caregiver burden by providing an additional source of support for the patient.
A one-on-one peer support program may be feasible for patients with head and neck cancer and their caregivers.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary objective:
I. Examine the feasibility of a peer support program for head and neck cancer patients.
Secondary objective:
I. Collect qualitative and quantitative data on the utilization of the mentorship program.
Exploratory objective:
I. Descriptive analysis of mentee psychosocial wellbeing over time. II. Descriptive analysis of caregiver burden over time.
Outline:
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
56
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alexandria Lichtl, MD
- Número de teléfono: 5037061729
- Correo electrónico: lichtl@ohsu.edu
Ubicaciones de estudio
-
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- OHSU Knight Cancer Institute
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Contacto:
- Ryan J. Li, MD
- Número de teléfono: 302-893-4959
- Correo electrónico: lry@ohsu.edu
-
Investigador principal:
- Ryan J. Li, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- MENTEE GROUP: Ability to understand and the willingness to sign a written informed consent document
- MENTEE GROUP: Willingness to have mentor-mentee interactions with the mentor selected by Imerman Angels (documented as part of informed consent)
- MENTEE GROUP: Age 18 or older at the time of consent (upper age limit 89)
- MENTEE GROUP: Diagnosed with head & neck cancer (all stages) and planning to receive, currently receiving or recently completed (within 12 months) active treatment OR in follow-up and reporting unmet social/support needs
- MENTEE GROUP: English-speaker
- MENTEE GROUP: Access to electronic device that can be used for communication
- MENTEE GROUP: Eastern Cooperative Oncology Group (ECOG) score less than or equal to 2
- CAREGIVER GROUP: Ability to understand and the willingness to sign a written informed consent document
- CAREGIVER GROUP: Age 18 or older at the time of consent (upper age limit 89)
- CAREGIVER GROUP: Caregiver of patient diagnosed with head and neck cancer who is also enrolled in the study
- CAREGIVER GROUP: English-speaker
- CAREGIVER GROUP: Access to electronic device that can be used for communication
Exclusion Criteria:
- MENTEE GROUP: Mentee must not be regularly engaging in other support programs at the start of the study intervention
- MENTEE GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- MENTEE GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
- CAREGIVER GROUP: Caregivers must not be regularly engaging in other support programs at the start of the study intervention
- CAREGIVER GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- CAREGIVER GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Supportive Care (peer support program)
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study. Caregivers of enrolled mentees may also participate on an optional basis by completing study surveys; however, caregivers will not directly participate in the peer mentorship intervention. |
Estudios complementarios
Estudios complementarios
Participate in peer support program
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of mentees meeting with their mentor match at least once
Periodo de tiempo: Up to 6 months
|
Will be reported with 95% asymptotic confidence interval.
|
Up to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Utilization of the mentorship program
Periodo de tiempo: Up to 6 months
|
Mean and standard deviation will be reported for number of times the mentor and mentee have made contact.
|
Up to 6 months
|
|
Mentorship conversation topics
Periodo de tiempo: Up to 6 months
|
Proportions of categories will be reported for topics discussed between mentor and mentee.
|
Up to 6 months
|
|
Rating scale for match
Periodo de tiempo: Up to 6 months
|
Mean and standard deviation will be reported for rating scale for match (in terms of similar demographics and cancer experience).
This will be on a 1-10 scale, with 10 being the most similar match.
|
Up to 6 months
|
|
Qualitative data on the benefits and challenges of the mentorship program
Periodo de tiempo: Up to 6 months
|
A subset of mentees (estimated n=10-15) will complete structured exit interviews at 6 months.
Interviews will explore perceived benefits, challenges, barriers to engagement, impact on decision-making, and recommendations for program improvement.
|
Up to 6 months
|
|
Satisfaction with peer mentor contacts
Periodo de tiempo: Up to 6 months
|
Satisfaction will be measured using a survey that was used in a prior pilot study on a one-on-one cancer peer support program by Valanjow and Weis (2024).
The survey contains 14 statements and mentees will be asked to rate how much they feel the statement applies.
The scale ranges from 1-5 (1= not applicable and 5=fully applies).
Mean and standard deviation of the Likert score will be reported for each item at each time point.
|
Up to 6 months
|
|
Demographic differences between matched mentees who meet with their mentor and those who do not
Periodo de tiempo: Up to 6 months
|
Descriptive univariate analysis to evaluate demographic differences between matched mentees who meet with their mentor and those who do not.
|
Up to 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mentee psychosocial well-being over time
Periodo de tiempo: Up to 6 months
|
Mentees will complete short surveys analyzing coping, anxiety and depression at three different time points to track changes over time.
|
Up to 6 months
|
|
Caregiver burden over time (optional)
Periodo de tiempo: Up to 6 months
|
Caregivers will complete surveys on caregiver burden at three different time points to track changes over time.
|
Up to 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ryan J Li, MD, OHSU Knight Cancer Institute
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias de Cabeza y Cuello
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Terapéutica
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Entrevistas como tema
- Cuidados paliativos
Otros números de identificación del estudio
- STUDY00029208 (Otro identificador: OHSU Knight Cancer Institute)
- NCI-2026-00407 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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