Cognitive rehabilitation for adults with low-grade gliomas
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
This study is testing if different types of cognitive rehabilitation, including an app and texting, can help adults with low-grade gliomas improve their thinking skills and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03948490 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of cognitive rehabilitation therapy in improving cognitive function in patients with low-grade gliomas, who often experience cognitive impairments affecting their daily lives. The study utilizes various methods, including an iPad app called ReMind, healthy SMS texting, in-person cognitive rehabilitation, and telehealth cognitive rehabilitation. The primary objectives include assessing the feasibility of these interventions and measuring cognitive decline over a 36-month follow-up period. Secondary objectives focus on changes in cognition and health-related quality of life at multiple time points post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed low-grade supratentorial primary brain tumors and subjective complaints of cognitive deficits.
Not a fit: Patients with glioblastoma or other types of brain tumors, as well as those unable to comply with study procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and quality of life for patients with low-grade gliomas.
How similar studies have performed: While cognitive rehabilitation has been established for traumatic brain injury and stroke, the feasibility and efficacy of these approaches in brain tumor patients remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 ≥ 3 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 * Are acutely suicidal, psychotic, and/or 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 primary brain tumor and either be undergoing definitive surgery or have had surgical resection within the last 4 months. * Prior surgery is allowed if they have not received additional tumor directed treatment. * \>= 18 years old * Must speak and be able to read English fluently. * Plan to continue to care in neuro-oncology at UCSF * Must be receiving MRI scans. Exclusion Criteria: * Diagnosis or evidence of any of the following: * • Glioblastoma * • Extra-axial disease (i.e. meningioma) * Are not able to comply with study and/or follow-up procedures * Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Jennie Taylor, MD, MPH — University of California, San Francisco
- Study coordinator: Jennie Taylor, MD, MPH
- Email: jennie.taylor@ucsf.edu
- Phone: 415-353-2966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.