C-SMART vs BE Well para Pacientes con Tumores Cerebrales
Ensayo Controlado Aleatorizado de Fase II de C-SMART frente a BE Well para Pacientes con Tumores Cerebrales sobre Resultados Neurocognitivos y de Neuroimagen
The goal of this clinical trial is to learn about the acceptability and feasibility of Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) and Brain health Education and Wellness (BE Well) in adults with brain tumors and their caregivers.
Participants will be assigned to one of the two groups:
- Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) is a recently developed virtual intervention combining both cognitive rehabilitation with mindfulness meditation training. The manualized program consists of 8 weekly 1:1 tele intervention sessions, targeting cognitive weaknesses identified from baseline cognitive testing.
- Brain health Education and Wellness (BE Well) intervention consists of 8 weekly videos focused on maximizing brain health in the context of brain tumor.
Participants will also be asked to:
- participate in two in-person visits involving an MRI (if eligible for research MRIs) and neurocognitive tests
- complete a survey the the beginning and end of the study
- if in BE Well group, answer a few questions after watching each video
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sarah Braun, Ph.D
- Número de teléfono: 804-628-7028
- Correo electrónico: sarah.braun@vcuhealth.org
Copia de seguridad de contactos de estudio
- Nombre: Brighton Payne, BS
- Número de teléfono: 804-628-6799
- Correo electrónico: brightonph@vcu.edu
Ubicaciones de estudio
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Reclutamiento
- Virginia Commonwealth University
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Contacto:
- Sarah Braun, Ph.D
- Número de teléfono: 804-628-7028
- Correo electrónico: sarah.braun@vcuhealth.org
-
Investigador principal:
- Sarah Braun, Ph.D
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Patient Inclusion Criteria:
- Patient of Virginia Commonwealth University Neuro-Oncology clinic
- Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
- At least one domain of neurocognitive function >1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded International Cognition and Cancer Task Force (ICCTF) clinical trials battery and Test of Premorbid Functioning (TOPF)62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
- Estimated premorbid intelligence using TOPF >75.
- Patients must be age 18+ and
- Primarily English speaking.
Patient Exclusion Criteria:
- Presence of major neurocognitive impairment that would prevent participation in the intervention, and/or severe aphasia, and/or inability to understand and provide informed consent
- Referred participants who are suspected to have major neurocognitive impairment will be administered the Telephone Interview for Cognitive Status (TICS) during the pre-screening phase. Scores of <20 indicate major neurocognitive impairment and will result in exclusion from study participation;
- Inability to attend weekly telehealth appointments
- Clinically significant insomnia symptoms coupled with report that insomnia is more interfering than cognitive symptoms
- < 1 month post brain surgery and/or radiation therapy
- Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
- Exclusion criteria for the MRI portion of the study includes (6)implants, objects, or devices that are not MR safe, as the MRI scan could cause them harm.
- Additionally, if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus. Those participants who have implants, objects, or devices that are not MRI safe and/or are pregnant but are otherwise eligible will participate in all other study activities, excluding MRI.
Caregiver Inclusion Criteria
- Must enroll with a patient (see criteria above)
- Must be age 18+ and
- Primarily English speaking
Caregiver Exclusion Criteria
-N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing |
|
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing |
|
Experimental: Brain health Education and Wellness (BE Well) - Patient
Time-matched educational videos focused on maximizing brain health in the context of brain tumor. |
Eight weekly 45- to 60-minute video lectures |
|
Experimental: Brain health Education and Wellness (BE Well) - Caregiver
Time-matched educational videos focused on maximizing brain health in the context of brain tumor. |
Eight weekly 45- to 60-minute video lectures |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
Periodo de tiempo: From time participant indicates interest to screening completion, 4 weeks
|
The percentage of participants that are eligible to enroll |
From time participant indicates interest to screening completion, 4 weeks
|
|
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate
Periodo de tiempo: From screening to intervention initiation, 8 weeks
|
The percentage of participants that enroll |
From screening to intervention initiation, 8 weeks
|
|
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate
Periodo de tiempo: From baseline to end of study, 28 weeks
|
The percentage of participants that complete the post-intervention data collection |
From baseline to end of study, 28 weeks
|
|
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rate
Periodo de tiempo: From baseline to end of intervention, 16 weeks
|
The percentage of participants that complete the the protocol assigned interventions |
From baseline to end of intervention, 16 weeks
|
|
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratings
Periodo de tiempo: From baseline to post-intervention survey completion, 20 weeks
|
Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that you would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group you were randomized to?" |
From baseline to post-intervention survey completion, 20 weeks
|
|
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.
Periodo de tiempo: From baseline to post-intervention survey completion, 20 weeks
|
Participant ratings of intervention recommendation Participants will answer the following question: Would "you" (the patient) recommend C-SMART/BE Well to other brain tumor patients? |
From baseline to post-intervention survey completion, 20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
Periodo de tiempo: From screening to intervention initiation, 8 weeks
|
The percentage of participants that enroll |
From screening to intervention initiation, 8 weeks
|
|
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor patients -- retention rate
Periodo de tiempo: From baseline to end of study, 28 weeks
|
The percentage of participants that complete the post-intervention data collection |
From baseline to end of study, 28 weeks
|
|
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant satisfaction ratings
Periodo de tiempo: From baseline to post-intervention survey completion, 20 weeks
|
Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that your loved one would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group your loved one was randomized to?" |
From baseline to post-intervention survey completion, 20 weeks
|
|
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant recommendation ratings.
Periodo de tiempo: From baseline to post-intervention survey completion, 20 weeks
|
Participant ratings of intervention recommendation. Participants will answer the following question: Would "you" (the caregiver) recommend C-SMART/BE Well to other caregivers? |
From baseline to post-intervention survey completion, 20 weeks
|
|
Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)
Periodo de tiempo: Baseline to post-intervention assessment, up to 28 weeks
|
Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Hopkins Verbal Learning Test (verbal learning and memory) neurocognitive test. Participant performance on the verbal learning and memory task will consist of three learning trials and a delay. A high score on the learning trials but a very low score on the delayed recall would show that the person can learn but has difficulty retrieving previously learned information. |
Baseline to post-intervention assessment, up to 28 weeks
|
|
Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)
Periodo de tiempo: Baseline to post-intervention assessment, up to 28 weeks
|
Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Controlled Oral Word Association (verbal fluency) neurocognitive test. Participant performance on the verbal fluency task will consist of generating words in 60 seconds on phonemic trials (words that start with a specific letter) and semantic trials (words that fall into a specific category). Scores are the number of correctly retrieved words. A higher raw score indicates greater verbal fluency. |
Baseline to post-intervention assessment, up to 28 weeks
|
|
Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)
Periodo de tiempo: Baseline to post-intervention assessment, up to 28 weeks
|
Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on Trail Making (processing speed and task switching). Participant performance will consist of time (in seconds) to complete a processing speed and switching task in which participants are asked to draw lines in sequential order, and then switch between two overlearned sequences. A shorter time to completion would indicate greater processing speed and task switching. |
Baseline to post-intervention assessment, up to 28 weeks
|
|
Investigate effect of interventions on subjective cognition
Periodo de tiempo: Baseline to post-intervention assessment, up to 20 weeks
|
Changes in subjective cognition (pre vs post intervention) between groups based on the Neuro-Qol Short Form the National Institutes of Health (NIH) toolbox. Participants rate their experience of cognitive slips on 4 questions from "never" to "very often", and 4 questions from "no difficulty" to "cannot do". Higher scores indicate greater subjective cognition. Scores range from 8-40. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population. |
Baseline to post-intervention assessment, up to 20 weeks
|
|
Investigate effect of interventions on fatigue
Periodo de tiempo: Baseline to post-intervention assessment, up to 20 weeks
|
Changes in fatigue (pre vs post intervention) between groups based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Participants rate their experience of fatigue on 4 items from "not at all" to "very much". Higher scores indicate greater fatigue. Scores range from 4-20. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population. |
Baseline to post-intervention assessment, up to 20 weeks
|
|
Structural brain changes
Periodo de tiempo: From baseline to post-outcome assessment, 28 weeks
|
Change in brain volume (pre vs. post intervention) between groups based on brain imaging (MRI) data. The volume of lateral ventricle in the hemisphere opposite to the tumor will be measured, using 3D Slicer (https://www.slicer.org) to calculate the ventricular volume at each time point which will serve as an index of diffuse cerebral volume loss. |
From baseline to post-outcome assessment, 28 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sarah Braun, Ph.D, Virginia Commonwealth University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-25-22557
- HM300000218 (Otro identificador: Virginia Commonwealth University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There are no plans to share individual patient data "IPD" at this time.
Información sobre medicamentos y dispositivos, documentos del estudio
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