NCT04667689

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

November 12, 2020

Last Update Submit

March 28, 2024

Conditions

Cancer-Related Cognitive DifficultiesCancer-Related Cognitive Impairment

Keywords

CancerCognition

Outcome Measures

Primary Outcomes (1)

  • Completion

    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 Outcomes (4)

  • Provider Action

    Post-Chemotherapy (16-18 weeks)

  • Changes in Cognition via NIH Toolbox Assessment

    Post-Chemotherapy (16-18 weeks)

  • Changes in Cognition via PROMIS Surveys

    Post-Chemotherapy (16-18 weeks)

  • Participant Feedback

    Post-Study (18-20 weeks)

Study Arms (1)

CAMPFIRE Assessment

OTHER

NIH Toolbox Cognitive Assessment and PROMIS Surveys

Behavioral: CAMPFIRE Online Cognitive Assessment for Cancer Patients

Interventions

CAMPFIRE Online Cognitive Assessment for Cancer PatientsBEHAVIORAL

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.

Also known as: CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system
CAMPFIRE Assessment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Michelle C Janelsins, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

December 16, 2020

Study Start

December 18, 2019

Primary Completion

September 16, 2022

Study Completion

January 4, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations

US(1)