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C-SMART vs BE Well for Brain Tumor Patients

This study is testing two behavioral programs, C-SMART and BE Well, for adults with brain tumors. C-SMART involves eight weekly one-on-one virtual sessions focusing on cognitive (thinking) skills and mindfulness. BE Well consists of eight weekly video lectures about brain health. The main goal is to see if these programs are practical and acceptable for patients and their caregivers. You might be able to join if you are an adult patient at Virginia Commonwealth University Neuro-Oncology clinic with a confirmed brain tumor and have some neurocognitive (brain-related thinking) weaknesses. The study plans to enroll 42 participants.

Study design
This study is an interventional study with 42 planned participants. Participants will be assigned to one of two groups: C-SMART or BE Well.
What's involved
You would participate in eight weekly 45-60 minute sessions, either one-on-one virtual sessions for C-SMART or video lectures for BE Well. The study will last for 28 weeks from baseline to the end.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline to the end of the study, which is 28 weeks.

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NCT07224503

C-SMART vs BE Well for Patients With Brain Tumors

Recruiting
NAAges 18+InterventionalSupportive care
Virginia Commonwealth University
~42 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:C-SMARTBE Well

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
Measured over From time participant indicates interest to screening completion, 4 weeks
+5 more outcomes measured

Conditions

Brain Tumor

Explore related trials

Brain Neoplasm

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Sarah Braun, Ph.D · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Sarah Braun, Ph.D
[email protected]
804-628-7028
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
N/A

What this trial measures

  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility RateFrom time participant indicates interest to screening completion, 4 weeks

    The percentage of participants that are eligible to enroll

  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment RateFrom screening to intervention initiation, 8 weeks

    The percentage of participants that enroll

  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rateFrom baseline to end of study, 28 weeks

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

  • Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rateFrom baseline to end of intervention, 16 weeks

    The percentage of participants that complete the the protocol assigned interventions

  • Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratingsFrom 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?"

  • Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.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?