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A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)

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ClinicalTrials.gov Identifier: NCT04824859
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Kah Poh Loh, University of Rochester

Study Description
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Brief Summary:
This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP in 50 older patients with cancer, their caregivers, and their oncology team. Using an iterative process, we will refine the eGAP based on input from stakeholders.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Behavioral Not Applicable

Detailed Description:
A geriatric assessment is a multidisciplinary diagnostic process that can detect medical, psychosocial and functional problems not identified by routine evaluation. This can subsequently guide management of the identified problems. However, the time and resources required to incorporate a geriatric assessment into clinic visits remain the primary barriers for implementation. There is a need to increase the adoption of the geriatric assessment among general oncologists and to address the associated resource limitations. Our long-term goal is to utilize an electronic platform to facilitate completion of the geriatric assessment. This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP) in 50 older patients with cancer, their caregivers, and oncology providers. Using an iterative process, we will refine the eGAP based on input from stakeholders (patients, caregivers, oncologists, nurses, advanced practitioners)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Electronic geriatric assessment platform to collect data (e.g., functional status, comorbidity, psychological health) that may better reflect health status of older adults with cancer
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
The eGAP consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on patient responses, tailored recommendations will be provided.
 Behavioral: Behavioral
eGAP that allows patients to complete validated questionnaires, and these questionnaires will be summarized and recommendations provided to the treating team


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility Retention Rate [ Time Frame: 1 week ]
    Percentage of patients completing the assessments that are assigned to them on eGAP


Secondary Outcome Measures :
  1. Recruitment rates [ Time Frame: 1 week ]
    Percentage of patients who are approached and agree to enroll

  2. Self-Report Completion Time [ Time Frame: 1 week ]
    Time spent on completing the self-reported assessments on the eGAP

  3. System Usability Scale [ Time Frame: 1 week ]
    For patients, caregivers, and oncology providers: score on 10-item scale, ranging 0-100; higher score corresponds to greater usability


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for patients:

  • Age ≥65 years
  • Have a diagnosis of cancer
  • Able to provide informed consent
  • English-speaking (because the platform is currently in English)

Inclusion criteria for caregivers:

  • Age ≥21 years
  • Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters".
  • Able to provide informed consent
  • English-speaking

Inclusion criteria for oncologists:

  • Oncologists, APPs, and nurses who care for the patient

Exclusion Criteria:

  • N/A
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824859


Contacts
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Contact: Kah Poh Loh 585-276-4353 Kahpoh_Loh@URMC.Rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kah Poh Loh    585-276-4353    Kahpoh_Loh@URMC.Rochester.edu   
Principal Investigator: Kah Poh Loh         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Kah Poh Loh University of Rochester
More Information
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Responsible Party: Kah Poh Loh, Senior Instructor, Department of Medicine, Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT04824859    
Other Study ID Numbers: UCCS21026
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The data will be available for 7 years from accrual of the first subject.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kah Poh Loh, University of Rochester:
Supportive Care
Cancer
mHealth
Geriatric