C-SMART vs BE Well for Patients With Brain Tumors

Официальное название

Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes

Обзор

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 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

Вмешательства

• Поведенческое C-SMART
  Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
• Поведенческое BE Well
  Eight weekly 45- to 60-minute video lectures

Первичные конечные точки

• Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate [Срок оценки: 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 [Срок оценки: From screening to intervention initiation, 8 weeks]
• Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From baseline to post-intervention survey completion, 20 weeks]

Вторичные конечные точки (10)

• Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From baseline to post-intervention survey completion, 20 weeks]
• Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory) [Срок оценки: Baseline to post-intervention assessment, up to 28 weeks]
• Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency) [Срок оценки: Baseline to post-intervention assessment, up to 28 weeks]
• Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching) [Срок оценки: Baseline to post-intervention assessment, up to 28 weeks]
• Investigate effect of interventions on subjective cognition [Срок оценки: Baseline to post-intervention assessment, up to 20 weeks]
• Investigate effect of interventions on fatigue [Срок оценки: Baseline to post-intervention assessment, up to 20 weeks]
• Structural brain changes [Срок оценки: From baseline to post-outcome assessment, 28 weeks]

Критерии участия

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 Functioning62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
• Estimated premorbid intelligence >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
• 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.
• Participants cannot have metal in their body as the MRI scan could cause them harm
• If female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus

Caregiver Inclusion Criteria

• Must enroll with a patient (see criteria above)
• Must be age 18+ and
• Primarily English speaking

Caregiver Exclusion Criteria

-N/A

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT07224503 · MCC-25-22557 · HM300000218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗