NCT04788758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

February 10, 2021

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • Positive predictive value of the G8

    Up to 30 months

Study Arms (1)

Health Services Research (G8 screening tool, referral)

EXPERIMENTAL

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: Educational InterventionOther: Screening Questionnaire AdministrationOther: ReferralOther: Questionnaire Administration

Interventions

Receive G8 screening tool administration training

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Health Services Research (G8 screening tool, referral)

Complete G8 screening tool

Health Services Research (G8 screening tool, referral)

Receive referral

Also known as: Referral, referral, Referred
Health Services Research (G8 screening tool, referral)

Ancillary studies

Health Services Research (G8 screening tool, referral)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefefrson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Early Intervention, EducationalEducational StatusMethodsReferral and Consultation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative TechniquesProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

March 9, 2021

Study Start

January 29, 2020

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations