C-SMART for Brain Cancer
(C-SMART Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Commonwealth University
Disqualifiers: Major neurocognitive impairment, severe aphasia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (N=36) A subset (n=10) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.
Will I have to stop taking my current medications?
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.
What data supports the effectiveness of the C-SMART treatment for brain cancer?
Research shows that mindfulness-based cognitive therapy (MBCT), a component of C-SMART, helps reduce depression and anxiety in cancer patients, improving their quality of life. Additionally, mindfulness-based stress reduction has been linked to lower psychological distress and better quality of life in head and neck cancer patients.
12345Is C-SMART safe for humans?
The studies reviewed do not provide specific safety data for C-SMART or related therapies like mindfulness and cognitive rehabilitation in humans, but they suggest these interventions are generally well-received and feasible for patients with brain tumors.
56789How is the C-SMART treatment for brain cancer different from other treatments?
C-SMART is unique because it combines cognitive strategies, mindfulness, and rehabilitation therapy to address cognitive deficits in brain cancer patients, unlike traditional treatments that focus primarily on medical or surgical interventions. This approach is similar to other cognitive rehabilitation programs but is distinct in its integration of mindfulness and strategy training to improve cognitive and real-life functioning.
67101112Eligibility Criteria
This trial is for adults with a glioma brain tumor who have finished radiation therapy at least a month ago. They should be able to perform daily activities well (KPS score ≥ 80), speak English, and show some cognitive decline compared to before their illness. People can't join if they can't attend online sessions, understand the study, or have severe sleep problems.Inclusion Criteria
I can care for myself but may not be able to carry out normal activities.
Ability to read, speak, and understand English
I have a confirmed primary brain tumor.
+2 more
Exclusion Criteria
I am able to understand and sign the consent form.
I cannot attend virtual sessions.
I have severe trouble sleeping.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
C-SMART Intervention
Participants receive the C-SMART intervention via telehealth, including neurocognitive testing and surveys
8-10 months
Telehealth sessions, in-person neurocognitive testing at baseline and post-intervention, surveys via secure email
Follow-up
Participants are monitored for satisfaction and retention post-intervention
1 month
Participant Groups
The C-SMART program is being tested in this study. It's delivered via telehealth and combines cognitive strategies, mindfulness techniques, and rehabilitation therapy aimed at helping patients with mild neurocognitive disorders due to gliomas.
1Treatment groups
Experimental Treatment
Group I: C-SMARTExperimental Treatment1 Intervention
C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
American Cancer Society, Inc.Collaborator
American Psychological FoundationCollaborator
References
Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. [2020]To assess the impact of an 8-week structured mindfulness-based cognitive therapy (MBCT) program on individuals experiencing distress as a consequence of cancer.
Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]This study explores satisfaction and changes in well-being in cancer patients following mindfulness-based stress reduction training.
Mindfulness-based cognitive therapy for individuals whose lives have been affected by cancer: a randomized controlled trial. [2018]This study evaluated the effectiveness of mindfulness-based cognitive therapy (MBCT) for individuals with a diagnosis of cancer.
Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study. [2022]People with head and neck cancer (HNC) experience elevated symptom toxicity and co-morbidity as a result of treatment, which is associated with poorer psychosocial and quality-of-life (QoL) outcomes. This Phase I study examined whether an individualised mindfulness-based stress reduction (IMBSR) programme could be successfully used with HNC patients undergoing curative treatment. Primary aims were to explore feasibility, compliance, acceptability and fidelity. Secondary aims were to determine whether (1) participation in the intervention was associated with changes in post-intervention mindfulness and (2) post-intervention mindfulness was associated with post-intervention distress and QoL. Nineteen HNC patients participated in a seven-session IMBSR programme with pre- and post-test outcome measures of psychological distress, depression, anxiety and QoL. Primary aims were assessed by therapists or participants. Mindfulness, distress and QoL were assessed using self-report questionnaires at pre- and post-intervention. Longer time spent meditating daily was associated with higher post-intervention mindfulness. After controlling for pre-intervention mindfulness, there was an association between higher post-intervention mindfulness and lower psychological distress and higher total, social and emotional QoL. This study offers important preliminary evidence than an IMBSR intervention can be administered to HNC patients during active cancer treatment. A randomised controlled trial is warranted to confirm these findings.
Using smart-messaging to enhance mindfulness-based cognitive therapy for cancer patients: A mixed methods proof of concept evaluation. [2021]Depression and anxiety lead to reduced treatment adherence, poorer quality of life, and increased care costs amongst cancer patients. Mindfulness-based cognitive therapy (MBCT) is an effective treatment, but dropout reduces potential benefits. Smart-message reminders can prevent dropout and improve effectiveness. However, smart-messaging is untested for MBCT in cancer. This study evaluates smart-messaging to reduce dropout and improve effectiveness in MBCT for cancer patients with depression or anxiety.
Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. [2020]Patients with brain tumors face unique quality of life challenges. Executive dysfunction is common and functionally limiting, with no established treatments as standard care. This pilot study evaluated the efficacy of Goal Management Training (GMT), a behavioral intervention combining mindfulness and strategy training, for improving executive and real-life functioning in this population.
Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. [2019]Many patients with primary brain tumors experience cognitive deficits. Cognitive rehabilitation programs focus on alleviating these deficits, but availability of such programs is limited. Our large randomized controlled trial (RCT) demonstrated positive effects of the cognitive rehabilitation program developed by our group. We converted the program into the iPad-based cognitive rehabilitation program ReMind, to increase its accessibility. The app incorporates psychoeducation, strategy training and retraining. This pilot study in patients with primary brain tumors evaluates the feasibility of the use of the ReMind-app in a clinical (research) setting in terms of accrual, attrition, adherence and patient satisfaction. The intervention commenced 3 months after resective surgery and patients were advised to spend 3 h per week on the program for 10 weeks. Of 28 eligible patients, 15 patients with presumed low-grade glioma or meningioma provided informed consent. Most important reason for decline was that patients (7) experienced no cognitive complaints. Participants completed on average 71% of the strategy training and 76% of the retraining. Some patients evaluated the retraining as too easy. Overall, 85% of the patients evaluated the intervention as "good" or "excellent". All patients indicated that they would recommend the program to other patients with brain tumors. The ReMind-app is the first evidence-based cognitive telerehabilitation program for adult patients with brain tumors and this pilot study suggests that postoperative cognitive rehabilitation via this app is feasible. Based on patients' feedback, we have expanded the retraining with more difficult exercises. We will evaluate the efficacy of ReMind in an RCT.
Interventions for cognitive deficits in patients with a brain tumor: an update. [2010]Patients with brain tumors may suffer from cognitive deficits caused by the disease and/or its treatment. Here, we review recent efforts in the research on prevention or treatment of cognitive deficits in these patients. We conclude that interest in this area is growing, but that methodological difficulties persist. In addition, we describe the recently completed first randomized controlled trial on the effectiveness of cognitive rehabilitation that we conducted in patients with brain cancer. By reflecting on the methodological challenges experienced in our trial, we hope to assist others in planning and conducting future studies on both pharmacological treatments and cognitive rehabilitation programs for cognitive deficits in this patient population. We conclude with suggestions for future research directions.
Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]Despite the large clinical interest in mindfulness, little is known about its effects in patients with brain tumours. Novel delivery methods such as App based Mindfulness training (AMT) may assist in the delivery of mindfulness treatment to this group of patients.
Long-term memory deficits in patients with malignant gliomas. [2019]Knowledge about the neuropsychological performance of adult patients with brain tumors, and especially with malignant gliomas, is limited. In this study 30 patients were consecutively included at time of diagnosis. Five months after completion of radiotherapy eleven of the patients showed no signs of focal neurology or tumor recurrence. These eleven patients, and their partners, were interviewed independently. Using each partner as control the patients were assessed neuropsychologically with special emphasis on memory abilities. The selective reminding technique was used with nouns of different visual imagery. A consistent pattern was found: there was no clear impairment in global intellectual abilities, but there was a pronounced deficit in long-term memory. However, the patients had a preserved capacity to use visual imagery to boost performance. It is important that medical staff acknowledge or confirm this problem. The sparing of imaginal coding makes it possible for the staff to assist with advice facilitating memory. Memory is a vital cognitive ability and the selective reminding technique was a sensitive method capable of detecting subtle impairments. The technique is recommended in future examinations of conditions and evaluations of treatments affecting the CNS.
Assessment and Management of Cognitive Symptoms in Patients With Brain Tumors. [2021]Cognitive symptoms occur in almost all patients with brain tumors at varying points in the disease course. Deficits in neurocognitive function may be caused by the tumor itself, treatment (surgery, radiation, or chemotherapy), or other complicating factors (e.g., seizures, fatigue, mood disturbance) and can have a profound effect on functional independence and quality of life. Assessment of neurocognitive function is an important part of comprehensive care of patients with brain tumors. In the neuro-oncology clinic, assessment may include cognitive screening tools and inquiry into subjective cognitive function. Neuropsychological assessment is an important adjunct to identify cognitive symptoms and can be used as an opportunity to intervene through transformative feedback and treatment planning. Preventative measures can be taken to reduce cognitive side effects of treatment, such as awake craniotomies with intraoperative mapping during neurosurgery or prophylactic measures during radiation therapy (e.g., hippocampal avoidance, neuroprotectant treatment with memantine). Rehabilitative therapies, including cognitive rehabilitation and computerized cognitive exercise, are options for managing cognitive problems in an individualized manner. Pharmacotherapy, including use of stimulant medications and acetylcholinesterase inhibitors, has shown benefits for patients with brain tumors when tailored to an individual's cognitive profile. Identification and management of co-occurring issues, such as sleep disturbance, fatigue, and depression, can also improve neurocognitive function. There are promising therapies under development that may provide new options for treatment in the future. Integrating careful assessment and treatment of cognition throughout the disease course for patients with brain tumors can improve functional outcomes and quality of life.
Functional Improvement After 4-Week Rehabilitation Therapy and Effects of Attention Deficit in Brain Tumor Patients: Comparison With Subacute Stroke Patients. [2020]To confirm functional improvement in brain tumor patients after 4-week conventional rehabilitation therapy, to compare the cognitive impairment of brain tumor patients with subacute stroke patients using computerized neuropsychological testing, and to determine the effects on functional outcomes of daily activity.