Virtual Group Resilient Living Program For Patients Living With Advanced Cancer
30 de junio de 2026 actualizado por: Deirdre R. Pachman, Mayo Clinic
This study is a prospective, minimal risk, non-randomized, single-arm study to determine feasibility and assess effectiveness of a Virtual Group Resilient Living Program (RLP) on anxiety, stress, quality of life (QOL), coping, and fatigue among patients with advanced cancer.
The group RLP is a psychosocial intervention that consists of a total of 7 weekly sessions in which the interventionalist teaches the patients techniques on stress management and building resilience (mindfulness, uplifting emotions, reframe experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness).
The group setting allows for support and connection amongst the patients, providing further support and motivation to practice the principles of the program.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
42
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: Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic in Rochester
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Contacto:
- Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
-
Investigador principal:
- Deirdre R. Pachman, MD
-
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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
No
Descripción
Inclusion Criteria:
- English fluency
- Diagnosis of advanced (stage III/IV) malignancy
- Baseline distress score ≥ 4/10. Patients can answer questions orally rather than complete worksheet, if applicable
- Life expectancy of ≥ 6 months
- Provide informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
- Has a reliable internet connection
- Has the ability to utilize technology to watch online modules, & participate in virtual sessions
Exclusion Criteria:
- As determined through self-report, those diagnosed with a history of a psychotic episode ≤ 5 years
- All psychological co-morbidities such as a history of untreated schizophrenia, & bipolar disease
- A diagnosis of severe cognitive impairment
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 |
|---|---|
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Experimental: Virtual Group Resilient Living Program
Participants will receive an invitation to 7 weekly 90-minute group RLP sessions.
Study participation involves attending RLP sessions, and completing brief surveys related to health, well-being, and quality of life.
There will also be online modules to watch and an accompanying journal (with prompts) to keep.
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The Resilient Living Program (RLP) is a virtual program consisting of online modules and virtual training sessions focused on techniques for managing stress and building resilience (mindful presence, uplifting emotions, and reframing experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness).
Otros nombres:
Participants will complete study-related surveys.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Enrollment Feasibility
Periodo de tiempo: Up to 1 year
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Enrollment feasibility will be met if 42 patients are enrolled within a year.
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Up to 1 year
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Completion Feasibility
Periodo de tiempo: Up to 1 year
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Completion feasibility will be met if at least 32 of 42 patients (≥75%) enrolled in the intervention arm attend at least 4 of the 7 program sessions.
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Up to 1 year
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Acceptability - Was it Worth it (WIWI)
Periodo de tiempo: After week 7 session
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measured by the three item responses from the Was It Worth It (WIWI) questionnaire.
Acceptability will be met if at least 75% of respondents answer "Yes" to at least two out of the three items
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After week 7 session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Anxiety - GAD-7
Periodo de tiempo: Baseline, after week 7 session, 30 days after week 7 session
|
Measured using the General Anxiety Disorder 7-item (GAD 7) scale, which is used to assess symptoms and feelings of anxiety over the past two weeks.
The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day).
The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
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Baseline, after week 7 session, 30 days after week 7 session
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Change in Stress - PSS
Periodo de tiempo: Baseline, after week 7 session, 30 days after week 7 session
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Measured using the 10-item Perceived Stress Scale (PSS), which is used to assess global perceived stress experienced by the participant over the preceding 30 days.
The PSS consists of 10 questions assessing how often the participant felt or thought a certain way during the past month.
Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often.
Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
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Baseline, after week 7 session, 30 days after week 7 session
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Change in Quality of Life (QoL) - FACT-G
Periodo de tiempo: Baseline, after week 7 session, 30 days after week 7 session
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Measured using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire used to assess health-related quality of life (HRQoL) in cancer patients.
Responses to each question are scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
Possible total scores range from 0-108, with higher scores indicating a better outcome/better QoL.
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Baseline, after week 7 session, 30 days after week 7 session
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Change in Coping - Brief COPE
Periodo de tiempo: Baseline, after week 7 session, 30 days after week 7 session
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Measured using the Brief COPE (Coping Orientation to Problems Experienced), a 28-item questionnaire used to assess the different coping styles a person uses to manage stress.
Each items is answered on a scale of 1 (I haven't been doing this at all) to 4 (I've been doing this a lot).
The Brief COPE consists of 14 subscales, i.e. active coping, planning, positive reframing, acceptance, humour, religion, use of emotional support, use of instrumental support, self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame, with two items per sub-scale.
Scores on each subscales ranges from 2 to 8 with higher scores representing most-used coping styles.
There is no overall composite score for this questionnaire.
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Baseline, after week 7 session, 30 days after week 7 session
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Change in Fatigue - PROMIS-Fatigue
Periodo de tiempo: Baseline, after week 7 session, 30 days after week 7 session
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Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue questionnaire, a subscale of the PROMIS-29, which is used to assess fatigue and related symptoms over the past seven days.
It consists of four items rated on a scale of 1(not at all) to 5 (very much).
Higher scores indicate greater experiences of fatigue.
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Baseline, after week 7 session, 30 days after week 7 session
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Deirdre R. Pachman, MD, Mayo Clinic
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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 (Actual)
19 de junio de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio 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
15 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MC250905
- 25-011765 (Otro identificador: Mayo Clinic Institutional Review Board)
- MNCCTN043 (Otro identificador: Minnesota Cancer Clinical Trials Network)
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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