C-SMART vs BE Well for Patients With Brain Tumors
ConditionBrain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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 (if eligible for research MRIs) 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
C-SMART
BehavioralEight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
BE Well
BehavioralEight weekly 45- to 60-minute video lectures
Treatment groups
56 Participants
are divided into 4 treatment groupsGroup A: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - PatientExperimental treatment 1 intervention
Group B: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - CaregiverExperimental treatment 1 intervention
Group C: Brain health Education and Wellness (BE Well) - PatientExperimental treatment 1 intervention
Group D: Brain health Education and Wellness (BE Well) - CaregiverExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From time participant indicates interest to screening completion, 4 weeks2
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate
The percentage of participants that enroll
Time frame
From screening to intervention initiation, 8 weeks3
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
Time frame
From baseline to end of study, 28 weeks4
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
Time frame
From baseline to end of intervention, 16 weeksSecondary outcomes
1
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
The percentage of participants that enroll
Time frame
From screening to intervention initiation, 8 weeks2
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor patients -- retention rate
The percentage of participants that complete the post-intervention data collection
Time frame
From baseline to end of study, 28 weeks3
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of 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 your loved one would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group your loved one was randomized to?"
Time frame
From baseline to post-intervention survey completion, 20 weeks4
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant recommendation ratings.
Participant ratings of intervention recommendation. Participants will answer the following question: Would "you" (the caregiver) recommend C-SMART/BE Well to other caregivers?
Time frame
From baseline to post-intervention survey completion, 20 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
American Psychological Foundation
Collaborator
Source ClinicalTrials.gov