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C-SMART versus BE Well voor Patiënten met Hersentumoren

21 september 2026 bijgewerkt door: Virginia Commonwealth University

Fase II Gerandomiseerde Gecontroleerde Studie van C-SMART versus BE Well voor Patiënten met Hersentumoren wat betreft Neurocognitieve en Neuroimaging Uitkomsten

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

56

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Werving
        • Virginia Commonwealth University
        • Contact:
        • Hoofdonderzoeker:
          • Sarah Braun, Ph.D

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
Gedragsmatig: C-SMART

Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
Experimenteel: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
Gedragsmatig: C-SMART

Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
Experimenteel: Brain health Education and Wellness (BE Well) - Patient

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
Gedragsmatig: BE Well

Eight weekly 45- to 60-minute video lectures
Experimenteel: Brain health Education and Wellness (BE Well) - Caregiver

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
Gedragsmatig: BE Well

Eight weekly 45- to 60-minute video lectures

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
Tijdsspanne: From time participant indicates interest to screening completion, 4 weeks

The percentage of participants that are eligible to enroll
From time participant indicates interest to screening completion, 4 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate
Tijdsspanne: From screening to intervention initiation, 8 weeks

The percentage of participants that enroll
From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate
Tijdsspanne: From baseline to end of study, 28 weeks

The percentage of participants that complete the post-intervention data collection
From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rate
Tijdsspanne: From baseline to end of intervention, 16 weeks

The percentage of participants that complete the the protocol assigned interventions
From baseline to end of intervention, 16 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratings
Tijdsspanne: From baseline to post-intervention survey completion, 20 weeks

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 you would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group you were randomized to?"
From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.
Tijdsspanne: From baseline to post-intervention survey completion, 20 weeks

Participant ratings of intervention recommendation Participants will answer the following question: Would "you" (the patient) recommend C-SMART/BE Well to other brain tumor patients?
From baseline to post-intervention survey completion, 20 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
Tijdsspanne: From screening to intervention initiation, 8 weeks

The percentage of participants that enroll
From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor patients -- retention rate
Tijdsspanne: From baseline to end of study, 28 weeks

The percentage of participants that complete the post-intervention data collection
From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant satisfaction ratings
Tijdsspanne: From baseline to post-intervention survey completion, 20 weeks

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?"
From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant recommendation ratings.
Tijdsspanne: From baseline to post-intervention survey completion, 20 weeks

Participant ratings of intervention recommendation. Participants will answer the following question: Would "you" (the caregiver) recommend C-SMART/BE Well to other caregivers?
From baseline to post-intervention survey completion, 20 weeks
Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)
Tijdsspanne: Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Hopkins Verbal Learning Test (verbal learning and memory) neurocognitive test. Participant performance on the verbal learning and memory task will consist of three learning trials and a delay. A high score on the learning trials but a very low score on the delayed recall would show that the person can learn but has difficulty retrieving previously learned information.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)
Tijdsspanne: Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Controlled Oral Word Association (verbal fluency) neurocognitive test. Participant performance on the verbal fluency task will consist of generating words in 60 seconds on phonemic trials (words that start with a specific letter) and semantic trials (words that fall into a specific category). Scores are the number of correctly retrieved words. A higher raw score indicates greater verbal fluency.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)
Tijdsspanne: Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on Trail Making (processing speed and task switching). Participant performance will consist of time (in seconds) to complete a processing speed and switching task in which participants are asked to draw lines in sequential order, and then switch between two overlearned sequences. A shorter time to completion would indicate greater processing speed and task switching.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on subjective cognition
Tijdsspanne: Baseline to post-intervention assessment, up to 20 weeks

Changes in subjective cognition (pre vs post intervention) between groups based on the Neuro-Qol Short Form the National Institutes of Health (NIH) toolbox. Participants rate their experience of cognitive slips on 4 questions from "never" to "very often", and 4 questions from "no difficulty" to "cannot do". Higher scores indicate greater subjective cognition. Scores range from 8-40. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.
Baseline to post-intervention assessment, up to 20 weeks
Investigate effect of interventions on fatigue
Tijdsspanne: Baseline to post-intervention assessment, up to 20 weeks

Changes in fatigue (pre vs post intervention) between groups based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Participants rate their experience of fatigue on 4 items from "not at all" to "very much". Higher scores indicate greater fatigue. Scores range from 4-20. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.
Baseline to post-intervention assessment, up to 20 weeks
Structural brain changes
Tijdsspanne: From baseline to post-outcome assessment, 28 weeks

Change in brain volume (pre vs. post intervention) between groups based on brain imaging (MRI) data. The volume of lateral ventricle in the hemisphere opposite to the tumor will be measured, using 3D Slicer (https://www.slicer.org) to calculate the ventricular volume at each time point which will serve as an index of diffuse cerebral volume loss.
From baseline to post-outcome assessment, 28 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Virginia Commonwealth University

Medewerkers

American Psychological Foundation

Onderzoekers

  • Hoofdonderzoeker: Sarah Braun, Ph.D, Virginia Commonwealth University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2025

Primaire voltooiing (Geschat)

31 oktober 2027

Studie voltooiing (Geschat)

31 oktober 2027

Studieregistratiedata

Eerst ingediend

31 oktober 2025

Eerst ingediend dat voldeed aan de QC-criteria

31 oktober 2025

Eerst geplaatst (Werkelijk)

4 november 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MCC-25-22557
  • HM300000218 (Andere identificatie: Virginia Commonwealth University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There are no plans to share individual patient data "IPD" at this time.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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