NCT02783495

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

May 22, 2016

Last Update Submit

January 14, 2020

Conditions

Glioma

Keywords

gliomaneurocognitivequality of life

Outcome Measures

Primary Outcomes (6)

  • 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

  • Patient-reported ease of use

    Questionnaire based measure of ease of use as a measure of feasibility.

    At 3 months after start of training

  • Patient-reported user satisfaction

    Questionnaire based measure of user satisfaction as a measure of feasibility.

    At 3 months after start of training

  • 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

  • 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

  • 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 Outcomes (2)

  • Improvement on neurocognitive testing

    At baseline, 3 months past training start, 9 months past training start

  • Subjective assessment of cognitive symptoms will be assessed

    At baseline, 3 months past training start, 9 months past training start

Study Arms (1)

Device: iPad

EXPERIMENTAL

Patients with brain tumors receive an iPad with the ReMind app. The patients will use the app to train neurocognitive and compensatory skills for 3 hours per week over the course of 12 weeks (36 hours in total)

Behavioral: Device: iPad

Interventions

Device: iPadBEHAVIORAL

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.

Device: iPad

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jennie W Taylor, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2016

First Posted

May 26, 2016

Study Start

July 19, 2016

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Subject data collected or generated as the result of participation in this study may be shared with co-investigators at the Tilburg University, The Netherlands, who developed the ReMind application. This may include clinical data, pathology data, imaging data, image files, and neurocognitive assessment results. All such data will be identified only by the subject's study code. All clinical research staff from The Netherlands will maintain all study materials in compliance with applicable laws, regulations and policies.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
July 2016- May 2019

Locations

US(1)