An Online Cognitive Assessment in Cancer Patients (CAMPFIRE)

March 28, 2024 updated by: Michelle Janelsins, PhD, MPH, University of Rochester

Phase II SBIR - CAMPFIRE: An Electronic Platform for Cognitive Assessment in Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CAMPFIRE Assessment
NIH Toolbox Cognitive Assessment and PROMIS Surveys
Behavioral: 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.
Other Names:
  • CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion
Time Frame: Post-Chemotherapy (16-18 weeks)
To determine the proportion of patients who complete the full-scope CAMPFIRE NIH PROMIS and NIH Toolbox battery throughout treatment (i.e., pre-chemotherapy time-point, 6-9 week time-point, post-chemotherapy time-point) Among the enrolled patients we will calculate proportions of patients who complete the full CAMPFIRE workflow at multiple time points: (1) at pre-chemotherapy; (2) at post-chemotherapy; and (3) at any time point in between. Similarly, proportions of completers will be calculated for each collection of measures for CAMPFIRE (NIH PROMIS and NIH Toolbox). The differences in completion of tests by age and gender will be compared. For individual tests, we will determine the proportion of patients completing the test and use descriptive statistics to summarize data. Descriptive statistics will be used to characterize the cohort of enrolled patients.
Post-Chemotherapy (16-18 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Action
Time Frame: Post-Chemotherapy (16-18 weeks)

To determine the proportion of patients for which the providers read and make any action (e.g., note in medical record, follow-up referral and types of follow-up referrals) based on the study assessments.

For each provider and time point, we will evaluate the number (and proportion) of patients for whom: (1) the provider read the assessment and made any type of note; and (2) the provider determined particular follow-up actions. We will evaluate the differences among providers and also the differences from pre- to post-chemotherapy for the same provider. We will describe the patterns of the type of follow-up action, if any, using quantitative analysis of referrals. It will be recorded if and when providers conduct any follow-up action, up to one month post-chemotherapy.

A Provider Behaviors Form will be completed by the study coordinator at each time-point to record information about CAMPFIRE data and how and when the provider responded to it.
Post-Chemotherapy (16-18 weeks)
Changes in Cognition via NIH Toolbox Assessment
Time Frame: Post-Chemotherapy (16-18 weeks)

To assess longitudinal changes in cognition from pre-treatment through follow-up using NIH Toolbox assessment tools. The assessment of cognition will include the following two NIH Toolbox tests: Picture Sequence Memory Test and and Flanker Inhibitory Control and Attention Test.

All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 6-9 week and post-chemotherapy time-points to baseline with t-tests and ANCOVAs adjusting for relevant covariates including age, sex, cancer type, chemotherapy regimen, and depression and anxiety scores. Additionally we will conduct linear mixed model analysis incorporating together data from all 3 time points.
Post-Chemotherapy (16-18 weeks)
Changes in Cognition via PROMIS Surveys
Time Frame: Post-Chemotherapy (16-18 weeks)

To assess longitudinal changes in cognition from pre-treatment through follow-up using NIH Toolbox assessment tools. The assessment of cognition will also include the PROMIS-Cognitive Function/Anxiety/Depression surveys. The PROMIS survey assessment scores will include subject's overall perceived symptom score, how it compares to the population median, and the results of 8 subdomains.

All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 6-9 week and post-chemotherapy time-points to baseline with t-tests and ANCOVAs adjusting for relevant covariates including age, sex, cancer type, chemotherapy regimen, and depression and anxiety scores. Additionally we will conduct linear mixed model analysis incorporating together data from all 3 time points.
Post-Chemotherapy (16-18 weeks)
Participant Feedback
Time Frame: Post-Study (18-20 weeks)

To qualitatively assess patient and provider feedback about the preferences for cognitive data type (self-report, objective) and workflow (timing of assessments, delivery methods of data).

Participants will complete a Feedback Survey within two weeks following their completion of the Post-Chemo assessment. Provider participants will complete a Feedback Survey at the time the first participant under their care completes the Post-Chemo assessment.

We will summarize the data from patients' and physicians' feedback forms, using frequencies and descriptive statistics. Feedback collected from participants and provider participants will be integrated and analyzed together. The focus will be on detecting systematic procedures in the CAMPFIRE application (e.g., flow) and cognitive assessment measures and outcome data presentation that work well and could be improved in order to inform the design of the future studies.
Post-Study (18-20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Charles River Analytics

Investigators

  • Principal Investigator: Michelle C Janelsins, Ph.D., University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Actual)

September 16, 2022

Study Completion (Actual)

January 4, 2024

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCS19151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer-Related Cognitive Difficulties

Clinical Trials on CAMPFIRE Online Cognitive Assessment for Cancer Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe