Clinical trial NCT02783495: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Official title: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glioma
Keywords: glioma
neurocognitive
quality of life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tilburg University
First posted: 2016-05-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects who complete the intervention
timeFrame: At 3 months after start of training
measure: Patient-reported ease of use
timeFrame: At 3 months after start of training
measure: Patient-reported user satisfaction
timeFrame: At 3 months after start of training
measure: Change in attention
timeFrame: At baseline, 3 months past training start, 9 months past training start
measure: Change in working memory
timeFrame: At baseline, 3 months past training start, 9 months past training start
measure: Change in Quality of Life
timeFrame: At baseline, 3 months past training start, 9 months past training start
Secondary outcomes:
measure: Improvement on neurocognitive testing
timeFrame: At baseline, 3 months past training start, 9 months past training start
measure: Subjective assessment of cognitive symptoms will be assessed
timeFrame: At baseline, 3 months past training start, 9 months past training start
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennie W Taylor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: