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Trial record 2 of 21 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | glioma | United States | First posted from 04/01/2019 to 07/31/2019

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

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ClinicalTrials.gov Identifier: NCT03948490
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : August 19, 2019
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.

Determine the feasibility of standard and innovative cognitive rehabilitation in lower grade gliomas (LrGG) patients. Feasibility will be the percentage of subjects who complete all of the intervention exercises. The intervention will be considered feasible for a larger-scale efficacy study if greater than 80% of the subjects complete the intervention. Cognitive and HRQOL will be assessed pre-intervention and compared to post-intervention (3 months from baseline) and 6-month (9 months from baseline) follow-up. Changes in cognition and HRQOL will be correlated with serial imaging at pre-intervention compared to short and intermediate-term follow-up e.g. in T2 tumor volume, Diffusion tensor imaging (DTI) scalar quantification, resting-state Functional magnetic resonance imaging (fMRI) connectivity.

Participants will first be offered the in-person cognitive rehabilitation option (Cohort 1). If they are unable to participate because of logistic challenges, they will randomly be assigned to the iPad based intervention (Cohort 2), or automated texting program (Cohort 3). Participants will complete standardized cognitive testing and quality of life assessments at baseline, immediately post intervention and 6 months after intervention. 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.

Predict optimal time for cognitive rehabilitation to abrogate tumor and treatment-related effects on cognition and HRQOL in adult LrGG. Enroll 100 newly diagnosed patients with a goal of enrolling 50 who will receive radiation treatment after surgery (Cohort 4) and 50 who will not receive radiation after surgery (Cohort 5). Patients in both groups 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.


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

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Study Type : Interventional
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

This study has 2 arms:

Arm 1 includes 3 interventions of cognitive rehab Cohort 1 - In-person rehab Cohort 2 - ReMind iPad app Cohort 3 - Healthy SMS texting Arm 2 includes 2 observational arms where patients will be followed longitudinally Cohort 4: Radiation after surgery Cohort 5: No radiation after surgery

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 : May 20, 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



Primary Outcome Measures :
  1. Arm1: Assess feasibility of each interventional Cohort independently - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 Short Message Service (SMS) texting. The intervention will be considered feasible with a less than 20% drop out rate. [ Time Frame: 9 months ]
    Assess feasibility of each interventional Cohort independently - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 SMS texting. The intervention will be considered feasible with a less than 20% drop out rate.

  2. 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. [ Time Frame: 3 years ]
    Detect a decline of greater than 1.5 standard deviation (SD) compared to baseline on the Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Working Memory Score or Hopkins Verbal Learning Test (HVLT) during the 36 month follow-up after surgery.


Secondary Outcome Measures :
  1. Arm 1: Measure changes in cognition for each cohort - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 SMS texting - at post-intervention (3 months from baseline) and 6 months (9 months from baseline) post-intervention [ Time Frame: 9 months ]
    Measure changes in cognition for each cohort - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 SMS texting - at post-intervention (3 months from baseline) and 6 months (9 months from baseline) post-intervention

  2. Arm 1: Measure changes in HRQOL for each cohort - Cohort 1 in-person; Cohort 2 ReMind; and Cohort 3 SMS texting - as captured by PROMIS-QOL - at post-intervention (3 months from baseline) and 6 months (9 months from baseline) post-intervention [ 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



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 WHO grade 2 or 3 gliomas
  • ≥ 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:

  • 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

Arm 2:

Inclusion Criteria:

  • Have a presumed world health organization (WHO) grade 2 or 3 gliomas and be undergoing definitive surgery at UCSF
  • ≥ 18 years old
  • Karnofsky performance status (KPS) of ≥ 70 (Appendix 6)
  • 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:

  • Are not able to comply with study and/or follow-up procedures
  • 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

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   
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     History of Changes
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: August 19, 2019
Last Verified: August 2019
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