C-SMART vs BE Well for Patients With Brain Tumors

Official title

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

Overview

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

Interventions

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

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07224503 · MCC-25-22557 · HM300000218

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗