Cancer-Related Cognitive DifficultiesCAMPFIRENCT04667689
An Online Cognitive Assessment in Cancer Patients
A study testing CAMPFIRE Online Cognitive Assessment for Cancer Patients in people with Cancer-Related Cognitive Difficulties and Cancer-Related Cognitive Impairment, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer-Related Cognitive Difficulties, Cancer-Related Cognitive Impairment
- What is being tested?
- CAMPFIRE Online Cognitive Assessment for Cancer Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- CAMPFIRE Online Cognitive Assessment for Cancer Patients
- Keywords
- Cancer, Cognition
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMPFIRE Online Cognitive Assessment for Cancer PatientsBehavioural
Also called CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system
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.
| Study group | Role | What they receive |
|---|---|---|
| CAMPFIRE Assessment | Other | NIH Toolbox Cognitive Assessment and PROMIS Surveys Receives: Behavioral: CAMPFIRE Online Cognitive Assessment for Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-Chemotherapy (16-18 weeks)
Secondary outcomes (4)
Provider Action
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.
Measured: Post-Chemotherapy (16-18 weeks)
Changes in Cognition via NIH Toolbox Assessment
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.
Measured: Post-Chemotherapy (16-18 weeks)
Changes in Cognition via PROMIS Surveys
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.
Measured: Post-Chemotherapy (16-18 weeks)
Participant Feedback
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.
Measured: Post-Study (18-20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start18 Dec 2019
- Primary completion16 Sep 2022
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-Related Cognitive DifficultiesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Charles River Analytics
- Responsible party
- Principal investigator, Michelle Janelsins, PhD, MPH, University of Rochester
- Investigators
- Michelle C Janelsins, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667689
- Sponsor's protocol ID
- UCCS19151
- Acronym
- CAMPFIRE
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2020
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II SBIR - CAMPFIRE: An Electronic Platform for Cognitive Assessment in Cancer Patients
- ClinicalTrials.gov ID
- NCT04667689
- Acronym / sponsor ID
- CAMPFIRE / UCCS19151
- Keywords
- Cancer, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Charles River Analytics
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAMPFIRE Assessment | Other | Behavioral: CAMPFIRE Online Cognitive Assessment for Cancer PatientsNIH Toolbox Cognitive Assessment and PROMIS Surveys |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMPFIRE Online Cognitive Assessment for Cancer PatientsAlso: CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) systemSubjects 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. | Behavioural | CAMPFIRE Assessment |
Primary outcome
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.
4 secondary outcomes
Provider Action
Time frame: Post-Chemotherapy (16-18 weeks)
Changes in Cognition via NIH Toolbox Assessment
Time frame: Post-Chemotherapy (16-18 weeks)
Changes in Cognition via PROMIS Surveys
Time frame: Post-Chemotherapy (16-18 weeks)
Participant Feedback
Time frame: Post-Study (18-20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle C Janelsins, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMPFIRE Online Cognitive Assessment for Cancer Patients in people with Cancer-Related Cognitive Difficulties and Cancer-Related Cognitive Impairment, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion (time frame: Post-Chemotherapy (16-18 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.