An Online Cognitive Assessment in Cancer Patients

NCT ID: NCT04667689

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2024-01-04

Brief Summary

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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

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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.

Conditions

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Cancer-Related Cognitive Difficulties Cancer-Related Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CAMPFIRE Assessment

NIH Toolbox Cognitive Assessment and PROMIS Surveys

Group Type OTHER

CAMPFIRE Online Cognitive Assessment for Cancer Patients

Intervention Type BEHAVIORAL

Subjects will complete PROMIS Cognitive Function/Anxiety/Depression survey assessments and a short neuropsychological battery (NIH Toolbox) on an iPad while in clinic prior to beginning chemotherapy, again before a clinic visit scheduled between 6 - 9 weeks and, lastly, before a post-chemotherapy follow-up clinic visit. Within two weeks of their post-chemotherapy assessment, subjects will be asked to complete a feedback survey. The physician providers and/or their clinical team (e.g., nurse practitioners, registered nurses) will be asked to review subjects' cognitive assessment results and discuss referrals and/or recommendations, if appropriate.

Interventions

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CAMPFIRE Online Cognitive Assessment for Cancer Patients

Subjects will complete PROMIS Cognitive Function/Anxiety/Depression survey assessments and a short neuropsychological battery (NIH Toolbox) on an iPad while in clinic prior to beginning chemotherapy, again before a clinic visit scheduled between 6 - 9 weeks and, lastly, before a post-chemotherapy follow-up clinic visit. Within two weeks of their post-chemotherapy assessment, subjects will be asked to complete a feedback survey. The physician providers and/or their clinical team (e.g., nurse practitioners, registered nurses) will be asked to review subjects' cognitive assessment results and discuss referrals and/or recommendations, if appropriate.

Intervention Type BEHAVIORAL

Other Intervention Names

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CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles River Analytics

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Michelle Janelsins, PhD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle C Janelsins, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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UCCS19151

Identifier Type: -

Identifier Source: org_study_id

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