Clinical trial NCT03948490: Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Official title: Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low-grade Glioma
Keywords: cognitive impairment
quality of life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: University of California, Berkeley
First posted: 2019-05-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Arm 1:

Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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:

Inclusion Criteria:

* Have a presumed low grade primary brain tumor and either be undergoing definitive surgery at UCSF or have had surgical resection at UCSF within the last 3 months.
* Prior surgery is allowed if they are coming to UCSF for definitive surgery and have not received additional systemic treatment or radiation.
* \>= 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.

Exclusion Criteria:

* Diagnosis or evidence of any of the following:
* • Glioblastoma
* • 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)

Primary outcomes:
measure: Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)
timeFrame: 9 months
measure: 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)
timeFrame: 3 years
Secondary outcomes:
measure: Improvement of ≥1.5 SD in at least one cognitive domain at post-intervention and/or follow-up for each Cohort (Arm 1)
timeFrame: 9 months
measure: 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)
timeFrame: 9 months
measure: Assess relation ships between cognitive changes and clinical factors (Arm 2)
timeFrame: 3 years
measure: Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (Arm 2)
timeFrame: 3 years
measure: Correlation of PROMIS-NeuroQOL scores and cognitive changes (Arm 2)
timeFrame: 3 years
measure: Correlation between isodose lines and cognitive changes (Arm 2)
timeFrame: 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennie Taylor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: