Geriatric Assessment Screening Tool for the Identification of At-Risk Older Adults Who Are Undergoing Cancer Treatment

Feasibility of Implementation and Assessment of Geriatric Assessment Screening Tool in Outpatient Oncology Clinic

This phase II trial investigates how easy it is to incorporate a nursing led geriatric assessment screening tool into a busy oncology practice, in order to identify at-risk older adults being evaluated for cancer treatment. This screening tool may help identify at-risk patients who can be referred for more in depth assessment, allowing for the creation of an individualized treatment plan that puts the patient's safety and personal goals as a priority.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Other: Screening Questionnaire Administration; Other: Referral

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of training nurses to administer the Geriatric 8 (G8) screening tool in an oncology practice, to identify older patients (> 65 years old [y/o]) that would benefit from a more extensive Comprehensive Geriatric Assessment (CGA).

SECONDARY OBJECTIVE:

I. To report the positive predictive value of the G8 screening tool with the final frailty designation determined by the Comprehensive Geriatric Assessment completed in patients referred to the Senior Adult Oncology Center (SAOC).

OUTLINE:

PHASE I:

Registered Nurses receive training on how to administer the G8 screening tool utilizing an Epic flowsheet to patients using a self-directed education module and by direct assessment by a geriatrician.

PHASE II:

Patients complete the G8 screening tool questionnaire over 10 minutes as part of their standard initial assessment, and their answers are entered into their electronic health record (EHR) flowsheet. Patients who score =< 14 on the G8 are referred for a CGA at SAOC, and these patients and their medical oncologists are made aware. Within 2 weeks of the initial screening, the results are communicated with the patient and medical oncologist at a 2-hour SAOC visit. Patients with a score of > 15 on the G8 are made aware of their results without any referral generated.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefefrson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• NURSES: Assigned to two designated cancer clinics at Sidney Kimmel Cancer Center (SKCC) Center City, the Renal Cell Carcinoma (RCC) and Lymphoma/myeloma clinics
• PATIENTS: 65 years and older
• PATIENTS: Diagnosis of cancer

Exclusion Criteria:

• PATIENTS: Inability to answer or have caregiver answer questions on screening tool

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health Services Research (G8 screening tool, referral); PHASE I: Registered Nurses receive training on how to administer the G8 screening tool utilizing an Epic flowsheet to patients using a self-directed education module and by direct assessment by a geriatrician. PHASE II: Patients complete the G8 screening tool questionnaire over 10 minutes as part of their standard initial assessment, and their answers are entered into their EHR flowsheet. Patients who score =< 14 on the G8 are referred for a CGA at SAOC, and these patients and their medical oncologists are made aware. Within 2 weeks of the initial screening, the results are communicated with the patient and medical oncologist at a 2-hour SAOC visit. Patients with a score of > 15 on the G8 are made aware of their results without any referral generated.

Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive G8 screening tool administration training; Other Names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational; Other: Screening Questionnaire Administration; Complete G8 screening tool; Other: Referral; Receive referral; Other Names: Referral, referral, Referred

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall assessment score: Pre	The score will be a number between 1-20. The responses to two questions of primary interest, assessing their comfort caring for older adults and their comfort in administering the G8 tool, will be binary measurements. The overall assessment scores from pre- and post- self-administered learning module will be compared using paired Wilcoxon test.	Before self-administered learning module
Overall assessment score: Post	The score will be a number between 1-20. The responses to two questions of primary interest, assessing their comfort caring for older adults and their comfort in administering the G8 tool, will be binary measurements. The overall assessment scores from pre- and post- self-administered learning module will be compared using paired Wilcoxon test.	After self-administered learning module
Number of patients screened	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Number of patients who refused	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Time it took to screen	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Number of referrals to Senior Adult Oncology Center (SAOC)	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Number of completed SAOC visits	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of the G8	The percentage of patients being determined as vulnerable/frail by Comprehensive Geriatric Assessment (CGA) at SAOC, i.e. the predictive positive value of G8, will be reported with its 95% confidence interval. The summary statistics of additional collected SAOC metrics including the Timed Up and Go test, prior history of falls, cognitive screen, depression screen, mortality prognostication, expected life expectancy, social distress thermometer, Mini Nutritional Assessment (MNA), presence of polypharmacy and inappropriate medications, and Eastern Cooperative Oncology Group (ECOG) score will be reported by means, standard deviations and percentages.	Up to 30 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 19E.925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No