C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Virginia Commonwealth University33 enrolled

Overview

The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (N=36) A subset (n=10) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glioma, Mixed Mild Neurocognitive Disorder Brain Tumor

Interventions

C-SMARTBEHAVIORAL

The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging 2. At least one domain of neurocognitive function \>1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded ICCTF clinical trials battery and Test of Premorbid Functioning for comparison 3. \>1 month post brain surgery and/or radiation therapy, if applicable 4. Estimated premorbid intelligence \>75. 5. Patients must be age 18+ and primarily English speaking Exclusion Criteria: 1. 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 2. Inability to attend weekly telehealth appointments; based on EAB results 3. Clinically significant insomnia symptoms 4. \< 1 month post brain surgery and/or radiation therapy 5. Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device. 6. To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Determine feasibility of C-SMART recruitment

As evidenced by rates of participant screening, eligibility, and consent

Time frame: 10 months

Determine feasibility of C-SMART - Data collection procedures

As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention

Time frame: 10 months

Determine feasibility of C-SMART - Retention Rate

As evidenced by the number of patients that complete post-intervention measures

Time frame: 11 months

Determine acceptability of C-SMART intervention - Satisfaction

After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.

Time frame: 10 months

Determine acceptability of C-SMART intervention - Satisfaction - Recommendation

As evidenced by the number of patients that would recommend the intervention to others

Time frame: 10 months

Optimization of C-SMART research procedures

The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa\>.80)

Data from ClinicalTrials.gov

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C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes