Geriatric Oncology Screening of Older Patients With Solid Cancers (PROGNOSIS-G8)

November 12, 2023 updated by: Helena Ditzel, Odense University Hospital

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study

Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Currently, there are no guidelines for oncogeriatric screening in older cancer patients in Denmark. We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA.

Aims:

  • Determine whether Danish cancer patients, with a G8 score of ≤14, experience poorer quality of life (QoL), receive less recommended standard cancer treatment, experience more treatment-related toxicity, stop treatment earlier, and experience shorter survival than patients with a G8 score >14.
  • Ascertain whether the standard G8 cut-off score of ≤14 is the most relevant cut-off score, with respect to treatment adherence, treatment-related toxicity, QoL, and survival, when focusing on the older Danish cancer patient population.
  • Establish whether the performance and prognostic value of the G8 can be strengthened through the addition of a functional measure, the 30-second chair stand test (30-CST), and/ or the handgrip strength test (HGST).
  • Evaluate the prognostic value of the modified Geriatric 8 (mG8)

Methods:

A prospective, descriptive study of all outpatients with newly diagnosed solid tumors at the Department of Oncology, Odense University Hospital, age 70 years or more. Patients will be screened with the G8, mG8, 30-CST, HGST, and QoL questionnaires at baseline with subsequent one-year follow-up, to determine the prognostic value of the G8 and the mG8. An initial two-month pilot study will help determine inclusion rates and highlight necessary practical adjustments to ensure optimal study participation. Baseline characteristics will be compared with descriptive statistics. Our primary endpoint; Global Health status/ QoL (EORTC QLQ-C30 & QLQ-ELD14), and secondary endpoints; treatment adherence, and treatment-related toxicity, will be assessed using logistical regression; while secondary endpoints; overall survival, cancer-specific survival, will be assessed using the Kaplan Meier analysis and Cox proportional hazard models. Post hoc diagnostic performance analysis will be conducted to determine the optimal G8 cut-off and whether functional measures (30-CST and HGST) can enhance screening accuracy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1401

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All outpatients, age 70 years or more with solid malignancies, referred to the Department of Oncology at Odense University Hospital for antineoplastic treatment or information

Description

Inclusion Criteria:

  • Patients age ≥70 with solid tumors (not hematological malignancies nor non-melanoma skin cancer) referred to the outpatient clinic at Odense University Hospital for information and/or antineoplastic treatment
  • Patients must be able to give informed consent
  • Patients must be able to speak English or Danish

Exclusion Criteria:

  • Patients who have received antineoplastic treatment for another cancer diagnosis within the past year
  • Patients who have begun chemotherapy or immunotherapy for the referred cancer diagnosis, more than 48 hours prior to the time of consent
  • Patients who have begun other antineoplastic treatment (not endocrine) for the referred cancer diagnosis, more than 7 days prior to the time of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older cancer patients
All outpatients, age 70 years or more, with solid malignancies, referred to the Department of Oncology at Odense University Hospital for 1st line antineoplastic treatment or information,
Diagnostic test: Geriatric 8
The G8 is an eight-item screening tool, developed for older cancer patients. The G8 score ranges from 0 (heavily impaired) to 17 (not at all impaired), with a cut-off for potential frailty of ≤14.
Other Names:
  • G8
Diagnostic test: modified Geriatric 8
The mG8 is a modified version of the Geriatric 8 screening tool, consisting of 6-items. The mG8 score ranges from 0 (not at all impaired) to 35 (heavily impaired), with a cut-off for potential frailty at ≥6.
Other Names:
  • mG8
Diagnostic test: 30 second chair stand test
Repetitions within 30 seconds
Other Names:
  • 30s-CST
  • chair stand test
  • 30 CST
  • CST
  • sit-to-stand test
  • 30 s chair stand test
Diagnostic test: Handgrip Strength Test
Measured in kilograms
Other Names:
  • HGST
  • HST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global health status / Quality of Life
Time Frame: 12 months
Global health status will be described using EORTC QLQ-C30
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life (HRQoL)
Time Frame: 12 months
HRQoL is measured by EORTC QLQ-C30
12 months
Health-related Quality of Life (HRQoL)
Time Frame: 12 months
HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)
12 months
Overall Survival
Time Frame: 12 months
Overall Survival is measured from Geriatric 8 screening to time of death
12 months
Cancer-specific Survival
Time Frame: 12 months
Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer
12 months
Adherence to initial oncologic treatment plan
Time Frame: 12 months
Deviation from initial oncologic treatment plan with the registration of dose reductions, with the given dose measured as a percentage of the planned dose.
12 months
Adherence to initial oncologic treatment plan
Time Frame: 12 months
Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.
12 months
Adherence to initial oncologic treatment plan
Time Frame: 12 months
Deviation from initial oncologic treatment plan with the registration of discontinuation of treatment, measured as the number of given cycles divided by the number of planned cycles.
12 months
Performance analysis of the Geriatric 8
Time Frame: 12 months
Performance analysis will be conducted using patients allocated to Comprehensive Geriatric Assessment (CGA), where an abnormal CGA will be defined as >1 abnormal domain, in accordance with the Danish version of the Geriatric Core Dataset (G-Code).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Danish Cancer Society
University of Southern Denmark
Academy of Geriatric Cancer Research

Investigators

  • Study Director: Marianne Ewertz, MD, DMSc, University of Southern Denmark
  • Study Chair: Jesper Ryg, MD, PhD, Department of Geriatric Medicin, Odense University Hospital
  • Study Chair: Cecilia M Lund, MD, PhD, Department of Clinical Medicin, Herlev and Gentofte Hospital
  • Study Chair: Trine L Jørgensen, MD, PhD, Department of Oncology, Odense University Hospital
  • Study Chair: Per Pfieffer, MD, PhD, Department of Oncology, Odense University Hospital
  • Study Chair: Henrik J Ditzel, MD, DMSc, Department of Oncology, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2020

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGNOSIS-G8
  • R247-A14382 (Other Grant/Funding Number: Danish Cancer Society)
  • 20/ 17768 (Other Identifier: Region of Southern Denmark)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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