Cognitive Strategies, Mindfulness & Rehabilitation (C-SMART) versus Brain Health Education and Wellness (BE Well) for adults with brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with primary brain tumors who show at least one domain of cognitive impairment are assigned to one of two 8-week interventions: C-SMART, which delivers 8 weekly one-on-one telehealth sessions targeting cognitive weaknesses identified at baseline, or BE Well, which provides 8 weekly brain health education videos. Participants complete baseline and end-of-study surveys and undergo two in-person visits for MRI and standardized neurocognitive testing. The C-SMART program is manualized and combines cognitive rehabilitation techniques with mindfulness meditation training tailored to each participant's test results. Feasibility, acceptability, and preliminary signals of cognitive or functional benefit are collected to inform larger trials.

Why it matters

Who can join: the full rules

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 Functioning (TOPF)62 for comparison; (3) \>1 month post brain surgery and/or radiation therapy, if applicable;
* Estimated premorbid intelligence using TOPF \>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
* Referred participants who are suspected to have major neurocognitive impairment will be administered the Telephone Interview for Cognitive Status (TICS) during the pre-screening phase. Scores of \<20 indicate major neurocognitive impairment and will result in exclusion from study participation;
* 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.
* Exclusion criteria for the MRI portion of the study includes (6)implants, objects, or devices that are not MR safe, as the MRI scan could cause them harm.
* Additionally, if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus. Those participants who have implants, objects, or devices that are not MRI safe and/or are pregnant but are otherwise eligible will participate in all other study activities, excluding MRI.

Caregiver Inclusion Criteria

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

Caregiver Exclusion Criteria

-N/A

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Sarah Braun, Ph.D — Virginia Commonwealth University
• Study coordinator: Sarah Braun, Ph.D
• Email: sarah.braun@vcuhealth.org
• Phone: 804-628-7028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.