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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948490
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
University of Tilburg
University of California, Berkeley
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Low-grade Glioma Device: ReMind iPad app Device: Healthy SMS texting Behavioral: In-person cognitive rehabilitation Behavioral: Telehealth cognitive rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Arm 1 Cohort 1: Interventional arm/In-person rehab

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

Behavioral: In-person cognitive rehabilitation
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.

Experimental: Arm 1 Cohort 2: Interventional arm/ReMind iPad app

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

Device: ReMind iPad app
Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.

Experimental: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting

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

Device: Healthy SMS texting
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.

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
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

Behavioral: 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




Primary Outcome Measures :
  1. Arm 1: Percentage of subjects who complete all of the intervention exercises for each cohort [ 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

  2. Arm 2: 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) [ 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


Secondary Outcome Measures :
  1. Arm 1: Improvement of ≥1.5 SD in at least one cognitive domain at post-intervention and/or follow-up for each Cohort [ Time Frame: 9 months ]
    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

  2. Arm 1: 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 [ Time Frame: 9 months ]
    Measure changes in HRQOL for each 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

  3. Arm2: Assess relation ships between cognitive changes and clinical factors [ Time Frame: 3 years ]
    Identify clinical factors (molecular subtype, age, tumor location, treatment) that correlate with ≥1.5 SD in at least one cognitive domain

  4. Arm 2: Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging [ Time Frame: 3 years ]
    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.

  5. Arm 2: Assess relationships between HRQOL and cognitive changes [ Time Frame: 3 years ]
    Correlate changes in HRQOL as measured by PROMIS-NeuroQOL with ≥1.5 SD in at least one cognitive domain

  6. Arm 2: Assess relationships between isodose lines and cognitive changes [ Time Frame: 3 years ]
    Correlate isodose lines for patients who received radiation with ≥1.5 SD in at least one cognitive domain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (Appendix 6)
  • 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 ≥ 6 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
  • Have acute psychiatric issues (suicidality, active psychosis, 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 supratentorial primary brain tumor and be undergoing definitive surgery at UCSF
  • >= 18 years old
  • Must speak and be able to read English fluently.
  • Prior biopsy is eligible if they have not received additional systemic treatment or radiation and definitive surgery is occurring with 1 year of biopsy
  • Plan to continue to care in neuro-oncology at UCSF
  • Must be receiving MRI scans at UCSF

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
  • Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948490


Contacts
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Contact: Jennie Taylor, MD, MPH 415-353-2966 jennie.taylor@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jennie W Taylor, MD, MPH    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Jennie W Taylor, MD, MPH         
Sponsors and Collaborators
University of California, San Francisco
University of Tilburg
University of California, Berkeley
Investigators
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Principal Investigator: Jennie Taylor, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03948490    
Other Study ID Numbers: 19103
NCI-2019-03245 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of California, San Francisco:
cognitive impairment
quality of life
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue