C-SMART vs BE Well for Patients With Brain Tumors

Virginia Commonwealth University (VCU)

Status: Suspended

Conditions: Brain Tumor

Treatments: Behavioral: C-SMART; Behavioral: BE Well

Study type: Interventional

Funder types: Other

Identifiers

NCT07224503

MCC-25-22557

HM300000218 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART)

Experimental group

Description:

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.

Treatment:

Behavioral: C-SMART

Brain health Education and Wellness (BE Well)

Active Comparator group

Description:

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.

Treatment:

Behavioral: BE Well