Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Jennie Taylor, MD, MPH
jennie.taylor@ucsf.edu
415-353-2966
Time Frame
Start Date: 2019-06-07
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 97
Treatments
Other: Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED)
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
Experimental: Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED)
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
Experimental: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED)
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
No_intervention: Arm 2 Cohort 4: Longitudinal arm/Upfront radiation
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
No_intervention: Arm 1 Cohort 5: Longitudinal arm/No upfront radiation
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
Other: Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation
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
Sponsors
Collaborators: Tilburg University, University of California, Berkeley
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov