C-SMART vs BE Well dla Pacjentów z Guzami Mózgu
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
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Sarah Braun, Ph.D
- Numer telefonu: 804-628-7028
- E-mail: sarah.braun@vcuhealth.org
Kopia zapasowa kontaktu do badania
- Nazwa: Brighton Payne, BS
- Numer telefonu: 804-628-6799
- E-mail: brightonph@vcu.edu
Lokalizacje studiów
-
-
Virginia
-
Richmond, Virginia, Stany Zjednoczone, 23298
- Rekrutacyjny
- Virginia Commonwealth University
-
Kontakt:
- Sarah Braun, Ph.D
- Numer telefonu: 804-628-7028
- E-mail: sarah.braun@vcuhealth.org
-
Główny śledczy:
- Sarah Braun, Ph.D
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
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. |
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. |
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. |
Eight weekly 45- to 60-minute video lectures |
Co mierzy badanie?
Podstawowe miary wyniku
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
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
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Sarah Braun, Ph.D, Virginia Commonwealth University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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)?
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
Bada produkt urządzenia regulowany przez amerykańską FDA
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