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

NCT ID: NCT07224503Sponsor: Virginia Commonwealth UniversityLast updated: 2026-04-17

Summary

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

Arms & interventions

  • BehavioralC-SMART

    Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing

  • BehavioralBE Well

    Eight weekly 45- to 60-minute video lectures

Outcome measures

Primary

  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate

    The percentage of participants that are eligible to enroll

    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

    The percentage of participants that enroll

    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

    The percentage of participants that complete the post-intervention data collection

    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

    The percentage of participants that complete the the protocol assigned interventions

    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

    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?"

    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.

    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?

    Time frame: From baseline to post-intervention survey completion, 20 weeks

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting
Sarah Braun, Ph.D · Contact
804-628-7028sarah.braun@vcuhealth.org
Sarah Braun, Ph.D · Principal Investigator