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C-SMART vs BE Well dla Pacjentów z Guzami Mózgu

21 września 2026 zaktualizowane przez: Virginia Commonwealth University

Faza II Randomizowane Badanie Kontrolowane Porównujące C-SMART z Programem BE Well dla Pacjentów z Guzami Mózgu pod Względem Wyników Neuropoznawczych i Neuroobrazowych

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

56

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • Rekrutacyjny
        • Virginia Commonwealth University
        • Kontakt:
        • Główny śledczy:
          • Sarah Braun, Ph.D

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient

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

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

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

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

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

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

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

Eight weekly 45- to 60-minute video lectures

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Virginia Commonwealth University

Współpracownicy

American Psychological Foundation

Śledczy

  • Główny śledczy: Sarah Braun, Ph.D, Virginia Commonwealth University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 grudnia 2025

Zakończenie podstawowe (Szacowany)

31 października 2027

Ukończenie studiów (Szacowany)

31 października 2027

Daty rejestracji na studia

Pierwszy przesłany

31 października 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 października 2025

Pierwszy wysłany (Rzeczywisty)

4 listopada 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MCC-25-22557
  • HM300000218 (Inny identyfikator: Virginia Commonwealth University)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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