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Completed

NCT Number: NCT05984667

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

The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • 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 ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
  • >1 month post brain surgery and/or radiation therapy, if applicable
  • Estimated premorbid intelligence >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
  • Inability to attend weekly telehealth appointments; based on EAB results
  • Clinically significant insomnia 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.
  • 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.

Caregiver Inclusion Criteria

  • Must be an adult caregiver of an enrolled patient (see criteria above)
  • Primarily English speaking

Caregiver Exclusion Criteria

  • Paid caregiver (e.g. home health aide)

Treatment and study plan

C-SMART

Behavioral

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.

Primary outcomes

  1. Determine feasibility of C-SMART recruitment

    Time frame: 10 months

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

  2. Determine feasibility of C-SMART - Data collection procedures

    Time frame: 10 months

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

  3. Determine feasibility of C-SMART - Retention Rate

    Time frame: 11 months

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

  4. Determine acceptability of C-SMART intervention - Satisfaction

    Time frame: 10 months

    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.

  5. Determine acceptability of C-SMART intervention - Satisfaction - Recommendation

    Time frame: 10 months

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

  6. Optimization of C-SMART research procedures

    Time frame: 8 months

    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)

  7. Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients

    Time frame: 10 months

    Completion rate of neuroimaging at post-intervention

Secondary outcomes

  1. Determine feasibility of C-SMART research procedures - Patient reported outcome completion

    Time frame: 10 months

    Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Cancer Society, Inc.
  • American Psychological Foundation

Registry information

Official study title

C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention

Acronym: C-SMART

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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