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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788758
• Other study ID #: 19E.925
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Educational Intervention
Receive G8 screening tool administration training
• Screening Questionnaire Administration
Complete G8 screening tool
• Referral
Receive referral
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefefrson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of patients screened	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Primary	Number of patients who refused	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Primary	Time it took to screen	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Primary	Number of referrals to Senior Adult Oncology Center (SAOC)	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Primary	Number of completed SAOC visits	Will be summarized by sample means, standard deviations and/or percentages.	Up to 30 months
Secondary	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