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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03948490
Status
Recruiting
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Conditions

  • Low-grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ReMind iPad app — DEVICE
    Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.
  • Healthy SMS texting — DEVICE
    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 rehabilitation — BEHAVIORAL
    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 rehabilitation — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jun 7, 2019
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1) [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Jennie W Taylor, MD, MPH
[email protected]
877-827-3222
Jennie W Taylor, MD, MPH (PRINCIPAL_INVESTIGATOR)

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