Skip to main content
Clinical Trials/NCT04788758
NCT04788758CompletedNot Applicable

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

Thomas Jefferson University1 site in 1 country76 target enrollmentStarted: January 29, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
Overall assessment score: Post

Study 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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Educational Intervention (Other)

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.

Intervention: Screening Questionnaire Administration (Other)

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.

Intervention: Referral (Other)

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.

Intervention: Questionnaire Administration (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.Aggressive B-cell NHL: FL grade 3b and DLBC
NL-OMON24909Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl60
Recruiting
Not Applicable
Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation.Recurrent aggressive B-cell lymphoma with CNS localisation, DLBCL, non-hodgkin lymphoma, NH
NL-OMON23427Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl35
Completed
Phase 1
Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress SyndromeAcute Respiratory Distress Syndrome
NCT04289194Histocell, S.L.26
Completed
Not Applicable
A clinical feasibility study to evaluate the effectiviness and safety of VivescOs TM as bone graft for reconstruction of intra-oral osseous defects.Intra-oral defects, due to loss of teeth/molars after trauma or extraction, were reconstructed with VivescOs.
NL-OMON24005Isotis, Bilthoven, the Netherlands10
Unknown
Not Applicable
Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for FallsAccidental FallsAgingVestibular Disorder
NCT04053829King's College London120