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

Summary

This study will evaluate the feasibility and efficacy of various cognitive rehabilitation treatments in patients with grade II-III glioma. 

With continually improving survival outcomes, patients with lower grade glioma are increasingly impacted by cognitive deficits caused by surgery, radiation, and/or chemotherapy. Such deficits include impaired attention, working memory, and other cognitive functions, which have a significant impact on quality of life. 

Cognitive rehabilitation includes therapeutic services designed to improve cognitive function. In practical terms, this often includes patient and family education, as well as cognitive exercises and strategies designed to address issues like forgetfulness and distractibility. The three cognitive rehabilitation strategies evaluated in this study include the following:

  • In-person cognitive rehabilitation: Participants will meet with a neuropsychologist who will conduct a comprehensive neuropsychological assessment, and then design and implement a rehabilitation plan. 
  • ReMind iPad App: Participants will use the ReMind iPad app, which was developed as an evidence-based program to improve attention and memory through game-like training sessions. This intervention was developed with collaborators at Tilburg University.
  • Healthy SMS Texting: Participants will receive a daily text message that focuses on patient-based, education-focused, health-related quality of life and cognitive education. This might include compensatory cognitive strategies, fatigue management, and coping skills. This intervention was developed with collaborators at Zuckerberg San Francisco General Hospital.

Eligible participants will first be offered the in-person cognitive rehabilitation treatment:

  • Cohort 1: In-person cognitive rehabilitation 

However, if participants cannot attend in-person sessions because of logistic challenges, they will be randomized to one of the following groups:

  • Cohort 2: ReMind iPad App (iPad-based intervention)
  • Cohort 3: Healthy SMS Texting (Automated texting program)

 

Inclusion Criteria

Arm 1:

  1. Histologically confirmed WHO grade 2 or 3 gliomas
  2. ≥ 18 years old
  3. Life expectancy > 12 weeks
  4. Karnofsky performance status (KPS) ≥ 70 (Appendix 6)
    Must speak and be able to read English fluently
  5. Must have access to the internet
  6. Must have text enabled cellphone
  7. Must be receiving MRI scans at University of California, San Francisco (UCSF)
  8. Must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 6 months
  9. Must be ≥ 6 months from craniotomy
  10. Must have subjective complaints of cognitive deficits
  11. Must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics
  12. Must score ≤ 1 SD below normal on ≥ 2 or more domains of baseline neuropsychological assessments

Arm 2:

  1. Have a presumed world health organization (WHO) grade 2 or 3 gliomas and be undergoing definitive surgery at UCSF
  2. ≥ 18 years old
  3. Karnofsky performance status (KPS) of ≥ 70 (Appendix 6)
  4. Must speak and be able to read English fluently.
  5. Prior biopsy is eligible if they have not received additional systemic treatment or radiation and definitive surgery is occurring with 1 year of biopsy
  6. Plan to continue to care in neuro-oncology at UCSF
  7. Must be receiving MRI scans at UCSF

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria

Arm 1:

  1. Are not able to comply with study and/or follow-up procedures
  2. 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: 

  1. Are not able to comply with study and/or follow-up procedures
  2. Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
  3. Patients who, based on the neuropsychologist's opinion, are unable to participate in cognitive testing and/or cognitive rehab secondary to significant neurologic deficit

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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