Clinical trial NCT04667689: An Online Cognitive Assessment in Cancer Patients
Official title: Phase II SBIR - CAMPFIRE: An Electronic Platform for Cognitive Assessment in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-Related Cognitive Difficulties
Cancer-Related Cognitive Impairment
Keywords: Cancer
Cognition
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Charles River Analytics
First posted: 2020-12-16
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the feasibility (acceptability and usability) and usefulness of the CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system, a patient-facing portal able to collect and produce reports for clinicians on Patient Reported Outcome Measurement Information System (PROMIS-Cognitive Function/Anxiety/Depression) outcomes via MyChart and NIH Toolbox, an inperson brief objective cognitive function battery. This study will aim to determine the value of the CAMPFIRE system for patients and providers as a tool for monitoring cognitive symptoms throughout the course of chemotherapy

Detailed description: CAMPFIRE is a health informatics platform and research tool that seeks to improve clinical research and treatment of cognitive sequelae of cancer and chemotherapy. CAMPFIRE provides curated digital assessments with content specifically for cognitive and psychosocial function assessment, and automates and integrates the data collection, analysis and visualization process into clinical workflows. CAMPFIRE is designed to both improve the availability of data on cognitive impairments among cancer patients, and to improve the integration of the produced data into the care process to efficiently improve outcomes. Key to the overall success of CAMPFIRE is the inclusion of well-validated measures to assess function in cognitive domains often affected in cancer patients, including attention, executive function, working memory, verbal and visuospatial abilities and verbal fluency.

The subjects will be asked to complete a cognitive assessment survey through a link to CAMPFIRE PROMIS in their MyChart account prior to beginning chemotherapy, between 6 - 9 weeks and prior to a post-chemotherapy follow up clinic visit. Subjects will also be asked to complete a brief cognitive assessment (NIH Toolbox) on an iPad in the JPWCI prior to their scheduled clinic visits at the same three study assessment time points.

Eligibility criteria: Inclusion Criteria:

* Must have diagnosis of cancer
* Must be scheduled to receive any standard course of curative intent cytotoxic chemotherapy
* Must have a computer, a general knowledge of how to use a computer and access to the internet
* Must be able to speak and read English
* Must be 21 years or older
* Must provide informed consent

Exclusion Criteria:

* Must not be currently hospitalized or have been hospitalized for any psychiatric illness within the last year
* Must not be diagnosed with neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
* Must not have any CNS disease (e.g., movement disorder, multiple sclerosis)

Primary outcomes:
measure: Completion
timeFrame: Post-Chemotherapy (16-18 weeks)
Secondary outcomes:
measure: Provider Action
timeFrame: Post-Chemotherapy (16-18 weeks)
measure: Changes in Cognition via NIH Toolbox Assessment
timeFrame: Post-Chemotherapy (16-18 weeks)
measure: Changes in Cognition via PROMIS Surveys
timeFrame: Post-Chemotherapy (16-18 weeks)
measure: Participant Feedback
timeFrame: Post-Study (18-20 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michelle C Janelsins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: