Cognitive Rehabilitation for Brain Tumor

Overseen By Jennie Taylor, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Anti-epileptics

Disqualifiers: Glioblastoma, Meningioma, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

97 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with glial brain tumors have increasingly improved outcomes, with median survival of 5-15 years. However, the treatments, including surgery, radiation, and chemotherapy, often lead to impaired attention, working memory, and other cognitive functions. These cognitive deficits frequently have significant impact on patient quality of life. Although currently, there is no established standard of care to treat cognitive deficits in brain tumor patients, standard cognitive rehabilitative treatments have been developed for those with traumatic brain injury and stroke. However, the feasibility and efficacy of these cognitive treatments in individuals with brain tumors remains unclear.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have adequate seizure control and be on a stable or decreasing dose of anti-epileptics.

What data supports the effectiveness of the treatment Cognitive Rehabilitation for Brain Tumor?

Research shows that cognitive rehabilitation programs, like the ReMind iPad app, can improve cognitive functions such as visual attention and verbal memory in brain tumor patients. Patients using these programs reported high satisfaction and would recommend them to others, indicating their potential effectiveness. ^{1 2 3 4 5}

Is cognitive rehabilitation safe for brain tumor patients?

The ReMind iPad app, a cognitive rehabilitation program for brain tumor patients, was well-received in a pilot study, with 85% of participants rating it as 'good' or 'excellent' and all recommending it to others, suggesting it is generally safe. ^{1 2 4 6 7}

How does the cognitive rehabilitation treatment for brain tumor patients differ from other treatments?

This treatment is unique because it offers cognitive rehabilitation through both in-person and telehealth (online) methods, making it more accessible to patients. The ReMind app, used in this treatment, is the first evidence-based cognitive telerehabilitation program specifically for adult brain tumor patients, incorporating psychoeducation, strategy training, and retraining exercises. ^{1 2 3 5 6}

Research Team

Jennie W Taylor, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 18 with low-grade brain tumors who speak English, have internet and text-enabled phones, are treated at UCSF, and have stable seizures. They must be post-surgery but not on recent tumor treatment, complain of cognitive issues, perform poorly on cognitive tests, and expect to live more than 12 weeks.

Inclusion Criteria

I am having or had brain surgery at UCSF for a low-grade tumor within the last 3 months.

You are expected to live for more than 12 weeks.

I feel like my memory or thinking skills have gotten worse.

Exclusion Criteria

I have been diagnosed with glioblastoma, meningioma, or infra-tentorial disease.

Are not able to comply with study and/or follow-up procedures

You are currently experiencing severe mental health issues such as suicidal thoughts, active psychosis, or being unable to take care of yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive rehabilitation therapy through various methods including in-person, telehealth, ReMind app, and SMS texting over 12 weeks

12 weeks

Every 2 weeks for in-person and telehealth; weekly for ReMind app; daily SMS

Follow-up

Participants are monitored for cognitive changes and quality of life at 3 and 9 months post-intervention

9 months

Assessments at 3 and 9 months

Longitudinal Follow-up

Participants undergo cognitive and quality of life assessments every 6 months for 3 years after surgery

36 months

Every 6 months

Treatment Details

Interventions

• Healthy SMS texting
• In-person cognitive rehabilitation
• ReMind iPad app
• Telehealth cognitive rehabilitation

Trial Overview The trial is testing if SMS texting reminders, a ReMind iPad app or telehealth sessions can help improve attention and memory in adults who've had surgery for low-grade brain tumors. It compares these methods to see which might aid recovery best.

Participant Groups

Group I: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED) Experimental Treatment 1 Intervention

The mobile phone texting intervention was developed with collaborators at Zuckerberg San Francisco General Hospital and is currently being studied in individuals with depression and traumatic brain injury. Participants receive a daily message sent at a random time (within their chosen timeframe(s); e.g. 9am-9pm). Messages will focus on patient-based education-focused health-related quality of life and cognitive education such as internal and external cognitive compensatory strategy training, fatigue management, and coping skills. n = 20 patients

Group II: Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED) Experimental Treatment 1 Intervention

The ReMind iPad-based cognitive rehabilitation was developed with collaborators at Tilburg University, The Netherlands, and is an evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors. Brain plasticity-based computerized cognitive training is a newly developing field of therapeutics for neurological and psychiatric disorders that uses frequent game-like training sessions to drive improvements in cognitive functions. n = 20 patients

Group III: Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation Experimental Treatment 1 Intervention

The telehealth cognitive rehabilitation will take place over secure UCSF Zoom. It will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning. During treatment implementation, patients acquire, apply, and adapt evidenced based strategies based on neuropsychological testing and conjointly developed treatment planning goals. N=20

Group IV: Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED) Experimental Treatment 1 Intervention

The in-person cognitive rehabilitation will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning. n = 20 patients

Group V: Arm 2 Cohort 4: Longitudinal arm/Upfront radiation Active Control 1 Intervention

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

Group VI: Arm 1 Cohort 5: Longitudinal arm/No upfront radiation Active Control 1 Intervention

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tilburg University

Collaborator

Trials

43

Recruited

21,300+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Findings from Research

A tablet-based cognitive rehabilitation program called ReMind was evaluated in 62 brain tumor patients, but it did not show significant improvements in cognitive performance or psychological outcomes compared to a control group.

Despite the lack of statistical significance in cognitive outcomes, participants reported high satisfaction with the program, indicating that while the intervention may not have been effective in this study, it could still be beneficial if tailored to better meet patients' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. van der Linden, SD., Rutten, GM., Dirven, L., et al.[2022]

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]

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]

A study involving 74 adults with cancer-related cognitive impairment showed that the Cognitive Retraining and Functional Treatment (CRAFT) program, which combines cognitive training and occupation-based treatment, significantly improved participation in daily life and cognitive performance compared to standard treatment.

CRAFT not only enhanced cognitive outcomes but also led to greater treatment satisfaction and maintained these benefits at a 3-month follow-up, indicating its potential as an effective intervention for improving quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Maeir, T., Makranz, C., Peretz, T., et al.[2023]

References

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

eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. [2022]

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

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

3. 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]

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

Cognitive rehabilitation for early post-surgery inpatients affected by primary brain tumor: a randomized, controlled trial. [2021]

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

Cognitive Rehabilitation in Patients with Gliomas and Other Brain Tumors: State of the Art. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. [2023]

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

Emerging From the Haze: A Multicenter, Controlled Pilot Study of a Multidimensional, Psychoeducation-Based Cognitive Rehabilitation Intervention for Breast Cancer Survivors Delivered With Telehealth Conferencing. [2020]