Low-grade GliomaNCT03948490
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
A study testing ReMind iPad app, Healthy SMS texting and In-person cognitive rehabilitation in people with Low-grade Glioma, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-grade Glioma
- What is being tested?
- ReMind iPad app, Healthy SMS texting and In-person cognitive rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed low grade supratentorial primary brain tumor
- >= 18 years old
- Life expectancy > 12 weeks
- Karnofsky performance status (KPS) >= 70
- Must speak and be able to read English fluently
- Must have access to the internet
Show all 19Show fewer
- Must have text enabled cellphone
- Must be receiving MRI scans at University of California, San Francisco (UCSF)
- Must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 3 months
- Must be >= 6 months from craniotomy
- Must have subjective complaints of cognitive deficits
- Must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics
- Must score <= 1 SD below normal on ≥ 2 or more domains of baseline neuropsychological assessments
- Have a presumed lower grade IDH-mutated primary brain tumor and either be undergoing definitive surgery or have had surgical resection within the last 4 months.
- Prior surgery is allowed if they have not received additional tumor directed treatment.
- >= 18 years old
- Must speak and be able to read English fluently.
- Plan to continue to care in neuro-oncology at UCSF
- Must be receiving MRI scans.
Who cannot join
- Diagnosis or evidence of any of the following:
- • Glioblastoma
- • Extra-axial disease (i.e. meningioma)
- • Infra-tentorial disease
- Are not able to comply with study and/or follow-up procedures
- Are unable to complete or score >= 3 cognitive tests at baseline, which is indicative that patients would be unable to complete the cognitive rehabilitation interventions
Show all 14Show fewer
- Are acutely suicidal, psychotic, and/or gravely disabled.
- Patients who, based on the neuropsychologist's opinion, are unable to participate in cognitive testing and/or cognitive rehab secondary to significant neurologic deficit
- Arm 2:
- Diagnosis or evidence of any of the following:
- • Primary brain tumor classified as CNS WHO Grade 4
- • Extra-axial disease (i.e. meningioma)
- Are not able to comply with study and/or follow-up procedures
- Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Jennie W Taylor, MD, MPH, 877-827-3222, cancertrials@ucsf.edu
Jennie W Taylor, MD, MPH
About this study
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.
Read the detailed description
This trial studies how well cognitive rehabilitation therapy works in improving cognitive function in patients with lower grade gliomas. Patients with low grade gliomas frequently have symptoms of cognitive impairment, such as difficulty with short term memory and processing information, that impacts their daily lives. The ReMind application (app) is an iPad app developed for cognitive rehabilitation for patients. The healthy texting platform was developed to help patients with depression and cognitive difficulty to provide education and track their mood. Methods of cognitive rehabilitation therapy such as in person cognitive rehabilitation, computerized cognitive rehabilitation, and healthy text messaging may help improve cognition and quality of life in patient with low grade gliomas.
PRIMARY OBJECTIVES:
- Assess feasibility of each interventional arm independently (Arm 1)
- Detect a decline of >= 1.5 standard deviation (SD) from baseline on the Wechsler Adult Intelligence Scale (WAIS)- IV Working Memory Score or Hopkins Verbal Learning Test (HVLT) during the 36 month follow-up after surgery. (Arm 2)
SECONDARY OBJECTIVES:
- Measure changes in cognition at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 1A telehealth; cohort 2 ReMind; and cohort 3 short message service (SMS) texting - at 3 months and 6 months post-intervention. (Arm 1)
- Measure changes in health related quality of life (HRQOL) at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 2 ReMind; and cohort 3 SMS texting - as captured by Patient Reported Outcomes Measurement Information System-quality of life (PROMIS-QOL) - at 3 months and 6 months post-intervention. (Arm 1)
- Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, treatment, and radiation fields when appropriate). (Arm 2)
- Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (T2 and contrast-enhancing tumor volume, diffusion tensor imaging (DTI) scalar quantification, structural connectivity, resting-state functional magnetic resonance imaging (fMRI) connectivity). (Arm 2)
- Assess relationships between HRQOL and cognitive changes. (Arm 2)
EXPLORATORY OBJECTIVES:
- Assess relationships between cognitive and HRQOL. (Arm 1)
- Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
- Assess relationships between HRQOL changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
- Assess relationships between cognitive changes and serial MR imaging (T2 and contrast-enhancing tumor volume, DTI scalar quantification, structural connectivity, resting-state fMRI connectivity). (Arm 1)
- Identify predictive power of tumor characteristics (tumor volume, location, molecular characteristics), patient characteristics (extent of resection, treatment, and radiation fields when appropriate), imaging characteristics (e.g. fMRI, DTI changes), and decline in cognition or HRQOL. (Arm 2)
OUTLINE:
Patients are invited to participant in Cohort 1A. Patients unable to participant in Cohort 1A are randomized to Cohort 2 or Cohort 3.
ARM 1:
- COHORT 1 (CLOSED): Patients receive standard in-person cognitive rehabilitation sessions with a neuropsychologist every 2 weeks over 1 hour each for 12 weeks.
- COHORT 1A: Patients receive telehealth cognitive rehabilitation with University of California, San Francisco (UCSF) Zoom visits with a neuropsychologist who specializes in brain tumors over 60 minutes every 2 weeks for 3 months.
- COHORT 2 (CLOSED): Patients receive computerized cognitive rehabilitation using the ReMind app over 3 hours per week for 12 weeks.
- COHORT 3 (CLOSED): Patients receive healthy text messages daily at random points during the week (Monday - Friday) for 12 weeks.
ARM 2:
- COHORT 4: Patients who receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, prior to start of radiation, at 4-6 week after radiation, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.
- COHORT 5: Patients who do not receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, within 1 month after surgery, 2-4 months after surgery, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.
After completion of study, patients in cohorts 1-3 are followed up at 3 and 9 months.
- Conditions
- Low-grade Glioma
- Being tested
- ReMind iPad app, Healthy SMS texting, In-person cognitive rehabilitation, Telehealth cognitive rehabilitation
- Keywords
- cognitive impairment, quality of life
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReMind iPad appDevice
Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.
Healthy SMS textingDevice
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.
In-person cognitive rehabilitationBehavioural
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.
Telehealth cognitive rehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED) | Other | 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 Receives: Behavioral: In-person cognitive rehabilitation |
| Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED) | Experimental | 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 Receives: Device: ReMind iPad app |
| Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED) | Experimental | 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 Receives: Device: Healthy SMS texting |
| Arm 2 Cohort 4: Longitudinal arm/Upfront radiation | No 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 |
| Arm 2 Cohort 5: Longitudinal arm/No upfront radiation | No 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 |
| Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation | Other | 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 Receives: Behavioral: Telehealth cognitive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)
The intervention will be considered feasible for a larger-scale efficacy study if greater than 80% of the subjects complete the intervention. Patients will be replaced if they drop out of the intervention (either by declining their first follow-up visit for Cohort 1 in-person rehab; declining to participate in the Cohort 2 ReMind intervention; or by texting the word "STOP" in the Cohort 3 short message service (SMS) texting intervention)) within the first 14 days. These patients will be replaced. All other patients will be evaluable for feasibility if they remain in the Cohort past the first 14 days of the intervention
Measured: 9 months
Number of participants who show a decline of >= 1.5 SD from baseline on the Wechsler Adult Intelligence Scale IV (WAIS-IV) Working Memory Score or Hopkins Verbal Learning Test (HVLT) (Arm 2)
Detect a decline of greater than 1.5 standard deviation (SD) compared to baseline on WAIS-IV Working Memory Score or HVLT during the 36 month follow-up after surgery
Measured: 3 years
Secondary outcomes (6)
Improvement of ≥1.5 SD in at least one cognitive domain at post-intervention and/or follow-up for each Cohort (Arm 1)
Changes in cognitive domains overtime will focus on changes in WAIS-IV Working Memory Score from baseline to post-intervention and/or follow-up within each cohort with a goal to detect the first time point at which there is at least a 1.5 standard deviation difference from baseline average
Measured: 9 months
Improvement of ≥1.5 SD in health related quality of life (HRQOL) as measured by Patient-Reported Outcomes Measurement Information System (PROMIS-NeuroQOL) at post-intervention and/or follow-up for each Cohort (Arm 1)
Measure changes in HRQOL for each Arm 1 cohort - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 SMS texting - as captured by Patient-Reported Outcomes Measurement Information System (PROMIS-QOL) - at post-intervention (3 months from baseline) and 6 months (9 months from baseline) post-intervention
Measured: 9 months
Assess relation ships between cognitive changes and clinical factors (Arm 2)
Identify clinical factors (molecular subtype, age, tumor location, treatment) that correlate with ≥1.5 SD in at least one cognitive domain
Measured: 3 years
Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (Arm 2)
Identify MR imaging characteristics (T2 FLAIR tumor volume at each imaging, T1 contrast enhancement volume at each imaging, Median, 10%, 90% apparent diffusion coefficient (ADC) and fractional anisotropy (FA) within T2 and T1 contrast tumor volumes, DTI scalar quantification and structural connectivity, Cerebral Blood Flow (CBF) within T2 and T1 contrast tumor volumes, Resting-state fMRI connectivity within the following major functional networks: default mode network, sensory/motor network, executive network, salience network, visual network and auditory network) at each time that correlate with >=1.5 SD in at least one cognitive domain.
Measured: 3 years
Correlation of PROMIS-NeuroQOL scores and cognitive changes (Arm 2)
The changes in HRQOL as measured by PROMIS-NeuroQOL will be correlated using Spearman's rank correlation changes in >=1.5 standard deviation on at least one cognitive domain. The PROMIS-NeuroQOL is a 5 item scale which measures how much difficulty specific tasks are to complete. Item scores range from 5="None" to 1="Cannot do". The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables and can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.
Measured: 3 years
Correlation between isodose lines and cognitive changes (Arm 2)
The isodose lines for patients who received radiation will be correlated using Spearman's rank correlation with changes in >=1.5 standard deviation on at least one cognitive domain. The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables and can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start7 Jun 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Jennie Taylor, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948490
- Sponsor's protocol ID
- 19103
- Other IDs
- NCI-2019-03245
- Status last verified
- Jul 2026
- First submitted
- 7 May 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- ClinicalTrials.gov ID
- NCT03948490
- Acronym / sponsor ID
- 19103
- Conditions
- Low-grade Glioma
- Keywords
- cognitive impairment, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tilburg University, University of California, Berkeley
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial studies how well cognitive rehabilitation therapy works in improving cognitive function in patients with lower grade gliomas. Patients with low grade gliomas frequently have symptoms of cognitive impairment, such as difficulty with short term memory and processing information, that impacts their daily lives. The ReMind application (app) is an iPad app developed for cognitive rehabilitation for patients. The healthy texting platform was developed to help patients with depression and cognitive difficulty to provide education and track their mood. Methods of cognitive rehabilitation therapy such as in person cognitive rehabilitation, computerized cognitive rehabilitation, and healthy text messaging may help improve cognition and quality of life in patient with low grade gliomas.
PRIMARY OBJECTIVES:
- Assess feasibility of each interventional arm independently (Arm 1)
- Detect a decline of >= 1.5 standard deviation (SD) from baseline on the Wechsler Adult Intelligence Scale (WAIS)- IV Working Memory Score or Hopkins Verbal Learning Test (HVLT) during the 36 month follow-up after surgery. (Arm 2)
SECONDARY OBJECTIVES:
- Measure changes in cognition at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 1A telehealth; cohort 2 ReMind; and cohort 3 short message service (SMS) texting - at 3 months and 6 months post-intervention. (Arm 1)
- Measure changes in health related quality of life (HRQOL) at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 2 ReMind; and cohort 3 SMS texting - as captured by Patient Reported Outcomes Measurement Information System-quality of life (PROMIS-QOL) - at 3 months and 6 months post-intervention. (Arm 1)
- Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, treatment, and radiation fields when appropriate). (Arm 2)
- Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (T2 and contrast-enhancing tumor volume, diffusion tensor imaging (DTI) scalar quantification, structural connectivity, resting-state functional magnetic resonance imaging (fMRI) connectivity). (Arm 2)
- Assess relationships between HRQOL and cognitive changes. (Arm 2)
EXPLORATORY OBJECTIVES:
- Assess relationships between cognitive and HRQOL. (Arm 1)
- Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
- Assess relationships between HRQOL changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
- Assess relationships between cognitive changes and serial MR imaging (T2 and contrast-enhancing tumor volume, DTI scalar quantification, structural connectivity, resting-state fMRI connectivity). (Arm 1)
- Identify predictive power of tumor characteristics (tumor volume, location, molecular characteristics), patient characteristics (extent of resection, treatment, and radiation fields when appropriate), imaging characteristics (e.g. fMRI, DTI changes), and decline in cognition or HRQOL. (Arm 2)
OUTLINE:
Patients are invited to participant in Cohort 1A. Patients unable to participant in Cohort 1A are randomized to Cohort 2 or Cohort 3.
ARM 1:
- COHORT 1 (CLOSED): Patients receive standard in-person cognitive rehabilitation sessions with a neuropsychologist every 2 weeks over 1 hour each for 12 weeks.
- COHORT 1A: Patients receive telehealth cognitive rehabilitation with University of California, San Francisco (UCSF) Zoom visits with a neuropsychologist who specializes in brain tumors over 60 minutes every 2 weeks for 3 months.
- COHORT 2 (CLOSED): Patients receive computerized cognitive rehabilitation using the ReMind app over 3 hours per week for 12 weeks.
- COHORT 3 (CLOSED): Patients receive healthy text messages daily at random points during the week (Monday - Friday) for 12 weeks.
ARM 2:
- COHORT 4: Patients who receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, prior to start of radiation, at 4-6 week after radiation, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.
- COHORT 5: Patients who do not receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, within 1 month after surgery, 2-4 months after surgery, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.
After completion of study, patients in cohorts 1-3 are followed up at 3 and 9 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED) | Other | Behavioral: In-person cognitive rehabilitationThe 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 |
| Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED) | Experimental | Device: ReMind iPad appThe 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 |
| Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED) | Experimental | Device: Healthy SMS textingThe 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 |
| Arm 2 Cohort 4: Longitudinal arm/Upfront radiation | No 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 |
| Arm 2 Cohort 5: Longitudinal arm/No upfront radiation | No 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 |
| Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation | Other | Behavioral: Telehealth cognitive rehabilitationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed low grade supratentorial primary brain tumor
- >= 18 years old
- Life expectancy > 12 weeks
- Karnofsky performance status (KPS) >= 70
- Must speak and be able to read English fluently
Key exclusion criteria (14 listed)
- Diagnosis or evidence of any of the following:
- • Glioblastoma
- • Extra-axial disease (i.e. meningioma)
- • Infra-tentorial disease
- Are not able to comply with study and/or follow-up procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMind iPad appEvidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors. | Device | Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED) |
| Healthy SMS textingParticipants 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. | Device | Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED) |
| In-person cognitive rehabilitationThe 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. | Behavioural | Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED) |
| Telehealth cognitive rehabilitationThe 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 | Behavioural | Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation |
Primary outcome
Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)
Time frame: 9 months
The intervention will be considered feasible for a larger-scale efficacy study if greater than 80% of the subjects complete the intervention. Patients will be replaced if they drop out of the intervention (either by declining their first follow-up visit for Cohort 1 in-person rehab; declining to participate in the Cohort 2 ReMind intervention; or by texting the word "STOP" in the Cohort 3 short message service (SMS) texting intervention)) within the first 14 days. These patients will be replaced. All other patients will be evaluable for feasibility if they remain in the Cohort past the first 14 days of the intervention
Number of participants who show a decline of >= 1.5 SD from baseline on the Wechsler Adult Intelligence Scale IV (WAIS-IV) Working Memory Score or Hopkins Verbal Learning Test (HVLT) (Arm 2)
Time frame: 3 years
Detect a decline of greater than 1.5 standard deviation (SD) compared to baseline on WAIS-IV Working Memory Score or HVLT during the 36 month follow-up after surgery
6 secondary outcomes
Improvement of ≥1.5 SD in at least one cognitive domain at post-intervention and/or follow-up for each Cohort (Arm 1)
Time frame: 9 months
Improvement of ≥1.5 SD in health related quality of life (HRQOL) as measured by Patient-Reported Outcomes Measurement Information System (PROMIS-NeuroQOL) at post-intervention and/or follow-up for each Cohort (Arm 1)
Time frame: 9 months
Assess relation ships between cognitive changes and clinical factors (Arm 2)
Time frame: 3 years
Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (Arm 2)
Time frame: 3 years
Correlation of PROMIS-NeuroQOL scores and cognitive changes (Arm 2)
Time frame: 3 years
Correlation between isodose lines and cognitive changes (Arm 2)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
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Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennie Taylor, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReMind iPad app, Healthy SMS texting and In-person cognitive rehabilitation in people with Low-grade Glioma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennie Taylor, MD, MPH (415-353-2966, jennie.taylor@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.