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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02783495
• Other study ID #: 16106
• Secondary ID: NCI-2017-01881
• Status: Terminated
• Phase: N/A
• Start date: July 19, 2016
• Est. completion date: January 17, 2019

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma

Intervention

Behavioral:
• Device: iPad
All patients will receive baseline neurocognitive and quality of life testing, followed by 3 months of the iPad-based intervention. At the end of the baseline visit, subjects will be lent an iPad to take home (or will be assisted in the installation of the ReMind app on their personal iPad) and instructed in the use of the ReMind app (and more basic iPad skills, if necessary). Subjects will review the intervention schedule (approximately 3 hours per week). Testing will be repeated 3 months after the baseline visit (i.e., immediately after the intervention) and 9 months after the baseline visit (i.e., 6 months after completion of the intervention), both time-points including a new MRI.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Tilburg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who complete the intervention	Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).	At 3 months after start of training
Primary	Patient-reported ease of use	Questionnaire based measure of ease of use as a measure of feasibility.	At 3 months after start of training
Primary	Patient-reported user satisfaction	Questionnaire based measure of user satisfaction as a measure of feasibility.	At 3 months after start of training
Primary	Change in attention	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)	At baseline, 3 months past training start, 9 months past training start
Primary	Change in working memory	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.	At baseline, 3 months past training start, 9 months past training start
Primary	Change in Quality of Life	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.	At baseline, 3 months past training start, 9 months past training start
Secondary	Improvement on neurocognitive testing	Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.	At baseline, 3 months past training start, 9 months past training start
Secondary	Subjective assessment of cognitive symptoms will be assessed	Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire	At baseline, 3 months past training start, 9 months past training start