Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients

Not Applicable

Terminated

• Conditions: Glioma

• Registration Number: NCT02783495
• Lead Sponsor: University of California, San Francisco

Brief Summary

This pilot clinical trial studies how well an iPad-based cognitive rehabilitation program works in improving quality of life in patients with grade II-III glioma. An iPad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-22
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Study Start: 2016-07-19
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patients must have histologically confirmed WHO grade 2 or 3 gliomas.
• Patients must be > 18 years old
• Patients must have a life expectancy > 12 weeks.
• Patients must have a Karnofsky performance status of > 70.
• This study was designed to include women and minorities, but was not designed to measure differences between them. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
• Patients must speak and be able to read English fluently.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
• Patients may not be known to be HIV-positive. HIV testing is not required for study participation.
• Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
• Patients must be receiving MRI scans at UCSF
• Patients must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 6 months
• Patients must be ≥ 6 months from craniotomy
• Patients must have subjective complaints of cognitive deficits.
• Patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics

Exclusion Criteria

• Patients who are not able to comply with study and/or follow-up procedures.
• Patients who do not have home access to the Internet.
• Patients who, based on the physician's opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in attention	At baseline, 3 months past training start, 9 months past training start	Evaluation of visual attention on the NIH Toolbox Flanker Inhibitory Control and Attention Test. The attention score ranges from 0 to 10 (10 = best performance)
Change in working memory	At baseline, 3 months past training start, 9 months past training start	Evaluation of working memory using the NIH Toolbox List Sorting Working Memory Test. Higher scores on each of these indicate higher levels of working memory.
Number of subjects who complete the intervention	At 3 months after start of training	Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).
Patient-reported user satisfaction	At 3 months after start of training	Questionnaire based measure of user satisfaction as a measure of feasibility.
Patient-reported ease of use	At 3 months after start of training	Questionnaire based measure of ease of use as a measure of feasibility.
Change in Quality of Life	At baseline, 3 months past training start, 9 months past training start	Measurement of general quality of life (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br), a multi-item questionnaire. Higher ratings suggest higher QOL.

Secondary Outcome Measures

Name	Time	Method
Improvement on neurocognitive testing	At baseline, 3 months past training start, 9 months past training start	Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.
Subjective assessment of cognitive symptoms will be assessed	At baseline, 3 months past training start, 9 months past training start	Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States