C-SMART vs BE Well for Patients With Brain Tumors

NCT07224503 | Recruiting DMC

• 2 other identifiers: MCC-25-22557HM300000218
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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?"

  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?

  From baseline to post-intervention survey completion, 20 weeks

Secondary Outcomes (10)

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

  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

  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

  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.

  From baseline to post-intervention survey completion, 20 weeks

• Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)

  Baseline to post-intervention assessment, up to 28 weeks

Study Arms (4)

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

EXPERIMENTAL

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

Behavioral: C-SMART

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

EXPERIMENTAL

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

Behavioral: C-SMART

Brain health Education and Wellness (BE Well) - Patient

EXPERIMENTAL

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

Behavioral: BE Well

Brain health Education and Wellness (BE Well) - Caregiver

EXPERIMENTAL

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

Behavioral: BE Well

Interventions

C-SMART BEHAVIORAL

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

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

BE Well BEHAVIORAL

Eight weekly 45- to 60-minute video lectures

Brain health Education and Wellness (BE Well) - Caregiver; Brain health Education and Wellness (BE Well) - Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• American Psychological Foundation: collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sarah Braun, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Braun, Ph.D

CONTACT

804-628-7028; sarah.braun@vcuhealth.org

Brighton Payne, BS

CONTACT

804-628-6799; brightonph@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Patients with primary brain tumor and their caregivers. 42 participants (24 patients and 18 caregivers)\[Anticipated\]

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)