C-SMART vs BE Well for Brain Cancer

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BP
Overseen ByBrighton Payne, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different programs to assess their impact on adults with brain tumors and their caregivers. One group will try C-SMART, which combines brain exercises with mindfulness meditation, while the other group will use BE Well, focusing on brain health through educational videos. The researchers aim to determine the feasibility and acceptability of these programs for participants. This trial suits adults who are patients at the Virginia Commonwealth University Neuro-Oncology clinic, have a confirmed brain tumor diagnosis, and experience cognitive difficulties. Participants must attend virtual sessions and complete surveys and tests during the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in brain health and caregiver support.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that C-SMART, which combines brain training and mindfulness meditation, remains quite new. Although specific safety data on C-SMART is lacking, similar therapies like mindfulness and brain training are generally well-tolerated. Previous studies have found these methods safe for many people, with few reports of negative effects.

The BE Well approach involves watching educational videos, a very low-risk activity. Watching videos about brain health is safe and shouldn't cause any harm.

Overall, both treatments in this trial—C-SMART and BE Well—are non-invasive, meaning they don't physically affect the body like surgery or medication might. This suggests they are likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for brain cancer because they explore innovative, non-pharmacological approaches to improve brain health and recovery. C-SMART combines cognitive rehabilitation with mindfulness meditation, a novel method aiming to enhance mental resilience and cognitive function in patients. This technique is distinct because it leverages the mind-body connection, potentially offering a more holistic recovery compared to conventional treatments like surgery, chemotherapy, or radiation. On the other hand, BE Well uses educational videos tailored to brain health, which could empower patients with knowledge and strategies to better manage their condition alongside traditional medical treatments. These approaches may provide complementary benefits to existing standards of care, potentially enhancing patients' quality of life and cognitive outcomes.

What evidence suggests that this trial's treatments could be effective for brain cancer?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that C-SMART, which combines brain training with mindfulness meditation, is a promising method for people with brain tumors. Early results from small studies suggest that C-SMART can improve thinking skills like memory and attention, often affected in these patients. This method is personalized, focusing on each person's specific thinking challenges. Meanwhile, the BE Well program, another treatment arm in this trial, uses videos to teach patients about brain health. While it aims to boost overall brain health, there is less direct evidence of its impact on thinking skills. Both treatments have potential, but C-SMART has more detailed early data supporting its effectiveness in improving thinking skills.23678

Who Is on the Research Team?

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Sarah Braun, Ph.D

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults with brain tumors and their caregivers. Participants will engage in two interventions involving cognitive strategies, mindfulness, or wellness education through virtual sessions or videos. They must be willing to undergo MRI scans, neurocognitive tests, and complete surveys.

Inclusion Criteria

Patient of Virginia Commonwealth University Neuro-Oncology clinic
Estimated premorbid intelligence >75
Must enroll with a patient (see criteria above)
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Exclusion Criteria

Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device
Participants cannot have metal in their body as the MRI scan could cause them harm
I do not have severe memory problems, speech issues, or trouble understanding that would stop me from participating.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either C-SMART or BE Well interventions over 8 weeks

8 weeks
8 virtual sessions for C-SMART, 8 video sessions for BE Well

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks
2 in-person visits for MRI and neurocognitive tests

What Are the Treatments Tested in This Trial?

Interventions

  • BE Well
  • C-SMART
Trial Overview The study compares C-SMART (a mix of cognitive rehabilitation and mindfulness meditation) with BE Well (wellness education videos). Each participant receives one of these 8-week programs to see which is more acceptable and feasible for improving the well-being of patients with brain tumors.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART)Experimental Treatment1 Intervention
Group II: Brain health Education and Wellness (BE Well)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

American Psychological Foundation

Collaborator

Trials
20
Recruited
2,200+

Citations

C-SMART vs BE Well for Patients With Brain TumorsThe goal of this clinical trial is to learn about the acceptability and feasibility of Cognitive Strategies, Mindfulness, and Rehabilitation ...
C-SMART: Cognitive Strategies, Mindfulness, and ...The primary aims of this mixed-methods trial are to test the feasibility and acceptability of the novel Cognitive Strategies, Mindfulness, and ...
P22.15.B THE DEVELOPMENT OF C-SMARTWe present the development and initial results from the pilot study of C-SMART (Cognitive Strategies, Mindfulness, and Rehabilitation Therapy), ...
P22.15.B THE DEVELOPMENT OF C-SMART: A NOVEL ...C-SMART is the first consensus-supported, individualized, mindfulness-based, cognitive rehabilitation intervention in neuro-oncology.
Researcher hopes to enhance wellbeing of brain cancer ...... Cognitive Strategies Mindfulness and Rehabilitation Therapy (C-SMART). C-SMART is tailored to patients with primary brain tumors and cognitive ...
C-SMART vs BE Well for Patients With Brain TumorsThe goal of this clinical trial is to learn about the acceptability and feasibility of Cognitive Strategies, Mindfulness, and Rehabilitation ...
C-SMART for Brain Cancer · Info for ParticipantsThe studies reviewed do not provide specific safety data for C-SMART or related therapies like mindfulness and cognitive rehabilitation in humans, but they ...
Get C-SMART: Massey neuropsychologist seeks to ...“C-SMART integrates cognitive rehabilitative therapy and mindfulness practices individualized to each patient to improve neurocognitive ...
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