C-SMART for Brain Cancer

(C-SMART Trial)

Overseen by Sarah E Braun, PhD

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. ^{1 2 3 4 5}

Is 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. ^{5 6 7 8 9}

How 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. ^{6 7 10 11 12}

Research Team

Sarah E Braun, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility 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.

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

Treatment Details

Interventions

• C-SMART (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: C-SMART Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Findings from Research

An 8-week mindfulness-based cognitive therapy (MBCT) program significantly reduced symptoms of depression and anxiety in 16 cancer survivors and their carers, with effects lasting up to 3 months after the intervention.

Increased mindfulness was correlated with decreased depression and anxiety scores, indicating that the MBCT program not only helps alleviate distress but also enhances mindfulness among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. Sharplin, GR., Jones, SB., Hancock, B., et al.[2020]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

Mindfulness-based cognitive therapy (MBCT) significantly improved mindfulness, depression, anxiety, and distress in 115 cancer patients after 8 weeks of treatment, indicating its effectiveness as a supportive therapy in oncology.

The study showed large effect sizes for improvements in mental health outcomes (e.g., depression effect size of 0.83), suggesting that MBCT can lead to clinically meaningful changes for individuals coping with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for individuals whose lives have been affected by cancer: a randomized controlled trial. Foley, E., Baillie, A., Huxter, M., et al.[2018]

The individualized mindfulness-based stress reduction (IMBSR) program was feasible and acceptable for 19 head and neck cancer patients undergoing treatment, suggesting it can be integrated into their care.

Higher levels of post-intervention mindfulness were linked to lower psychological distress and improved quality of life, indicating that mindfulness practices may benefit patients during active cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study. Pollard, A., Burchell, JL., Castle, D., et al.[2022]

In a study involving 51 cancer patients undergoing mindfulness-based cognitive therapy (MBCT), those who used smart-message reminders were eight times more likely to complete the program compared to those who did not use the reminders.

Patients using smart-messaging also experienced significantly greater improvements in depression symptoms throughout the therapy, suggesting that this intervention can enhance the effectiveness of MBCT for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using smart-messaging to enhance mindfulness-based cognitive therapy for cancer patients: A mixed methods proof of concept evaluation. Wells, C., Malins, S., Clarke, S., et al.[2021]

Goal Management Training (GMT) significantly improved executive functions and real-life functioning in 25 brain tumor survivors, with benefits maintained at a 4-month follow-up.

Participants in the GMT group reported fewer cognitive concerns and achieved greater functional goal attainment compared to those in the active control and wait-list groups, suggesting that GMT is a promising intervention for cognitive dysfunction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. Richard, NM., Bernstein, LJ., Mason, WP., et al.[2020]

The ReMind app, an iPad-based cognitive rehabilitation program, was found to be feasible for patients with primary brain tumors, with 85% of participants rating it as 'good' or 'excellent' and expressing willingness to recommend it to others.

In a pilot study involving 15 patients, participants completed a significant portion of the training (71% strategy training and 76% retraining), indicating good adherence, although some found the exercises too easy, leading to plans for more challenging content in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. van der Linden, SD., Sitskoorn, MM., Rutten, GM., et al.[2019]

There is a growing interest in addressing cognitive deficits in patients with brain tumors, but significant methodological challenges remain in conducting effective research in this area.

The first randomized controlled trial on cognitive rehabilitation for brain cancer patients has been completed, providing insights that may help improve future studies on both cognitive rehabilitation and pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for cognitive deficits in patients with a brain tumor: an update. Gehring, K., Aaronson, NK., Taphoorn, MJ., et al.[2010]

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., et al.[2021]

In a study of 30 adult patients with brain tumors, particularly malignant gliomas, long-term memory deficits were identified five months after radiotherapy, despite no overall impairment in global intellectual abilities.

The use of visual imagery helped patients enhance their memory performance, suggesting that medical staff can support these patients by utilizing techniques that leverage their preserved imaginal coding abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term memory deficits in patients with malignant gliomas. Salander, P., Karlsson, T., Bergenheim, T., et al.[2019]

Cognitive symptoms are common in brain tumor patients and can significantly impact their quality of life, making neurocognitive assessment a crucial part of their care.

Preventative and rehabilitative strategies, such as awake craniotomies, cognitive rehabilitation, and tailored pharmacotherapy, can effectively manage cognitive deficits and improve functional outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and Management of Cognitive Symptoms in Patients With Brain Tumors. Parsons, MW., Dietrich, J.[2021]

A 4-week conventional rehabilitation therapy significantly improved functional outcomes in both brain tumor patients and subacute stroke patients, indicating its effectiveness in enhancing daily activity functions.

In brain tumor patients, initial cognitive and motor assessments were strong predictors of their daily activity function, suggesting that targeted cognitive training could further enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Improvement After 4-Week Rehabilitation Therapy and Effects of Attention Deficit in Brain Tumor Patients: Comparison With Subacute Stroke Patients. Han, EY., Chun, MH., Kim, BR., et al.[2020]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for individuals whose lives have been affected by cancer: a randomized controlled trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Using smart-messaging to enhance mindfulness-based cognitive therapy for cancer patients: A mixed methods proof of concept evaluation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Interventions for cognitive deficits in patients with a brain tumor: an update. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Long-term memory deficits in patients with malignant gliomas. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Assessment and Management of Cognitive Symptoms in Patients With Brain Tumors. [2021]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Functional Improvement After 4-Week Rehabilitation Therapy and Effects of Attention Deficit in Brain Tumor Patients: Comparison With Subacute Stroke Patients. [2020]