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Clinical Trials/NCT04788758
NCT04788758
Completed
Not Applicable

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

Thomas Jefferson University1 site in 1 country76 target enrollmentJanuary 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Sponsor
Thomas Jefferson University
Enrollment
76
Locations
1
Primary Endpoint
Overall assessment score: Post
Status
Completed
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 29, 2020
End Date
May 25, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Overall assessment score: Post

Time Frame: After self-administered learning module

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.

Number of patients screened

Time Frame: Up to 30 months

Will be summarized by sample means, standard deviations and/or percentages.

Time it took to screen

Time Frame: Up to 30 months

Will be summarized by sample means, standard deviations and/or percentages.

Number of completed SAOC visits

Time Frame: Up to 30 months

Will be summarized by sample means, standard deviations and/or percentages.

Number of patients who refused

Time Frame: Up to 30 months

Will be summarized by sample means, standard deviations and/or percentages.

Overall assessment score: Pre

Time Frame: Before self-administered learning module

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.

Number of referrals to Senior Adult Oncology Center (SAOC)

Time Frame: Up to 30 months

Will be summarized by sample means, standard deviations and/or percentages.

Secondary Outcomes

  • Positive predictive value of the G8(Up to 30 months)

Study Sites (1)

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