Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07224503

C-SMART vs BE Well for Patients With Brain Tumors

Led by Virginia Commonwealth University · Updated on 2026-04-17

42

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

V

Virginia Commonwealth University

Lead Sponsor

A

American Psychological Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

C-SMART vs BE Well for Patients With Brain Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 more than 1.5 standard deviations below average or estimated premorbid functioning
  • More than 1 month post brain surgery and/or radiation therapy, if applicable
  • Estimated premorbid intelligence greater than 75
  • Age 18 years or older
  • Primarily English speaking
  • Caregivers must enroll with a patient meeting the above criteria
  • Caregivers must be age 18 years or older
  • Caregivers must be primarily English speaking
Not Eligible

You will not qualify if you...

  • Major neurocognitive impairment preventing participation, severe aphasia, or inability to understand and provide informed consent
  • Inability to attend weekly telehealth appointments
  • Clinically significant insomnia symptoms that interfere more than cognitive symptoms
  • Less than 1 month post brain surgery and/or radiation therapy
  • Unstable internet connection or inability to use teleconferencing software (an iPad will be provided if needed)
  • Presence of metal in the body preventing safe MRI
  • Pregnancy in females of childbearing years due to MRI risks

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

S

Sarah Braun, Ph.D

CONTACT

B

Brighton Payne, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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