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Trial record 2 of 23 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

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Arm1: 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. [ 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.
  • 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 WAIS-IV Working Memory Score or HVLT during the 36 month follow-up after surgery.
Change History Complete list of historical versions of study NCT03948490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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
  • 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 PROMIS-QOL - at post-intervention (3 months from baseline) and 6 months (9 months from baseline) post-intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Official Title  ICMJE Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Low-grade Glioma
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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

    Intervention: Behavioral: In-person cognitive rehabilitation
  • 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

    Intervention: Device: ReMind iPad app
  • 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

    Intervention: Device: Healthy SMS texting
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennie Taylor, MD, MPH 415-353-2966 jennie.taylor@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948490
Other Study ID Numbers  ICMJE 19103
NCI-2019-03245 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of Tilburg
  • University of California, Berkeley
Investigators  ICMJE
Principal Investigator: Jennie Taylor, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP