Geriatric Oncology Screening of Older Patients With Solid Cancers

Cancer Clinical Trial

— PROGNOSIS-G8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644874
• Other study ID #: PROGNOSIS-G8
• Secondary ID: R247-A1438220/ 1
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1401
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age
• Cancer
• Frailty
• Geriatrics
• Screening
• Solid Carcinoma

Intervention

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.
• 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.
• 30 second chair stand test
Repetitions within 30 seconds
• Handgrip Strength Test
Measured in kilograms

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Academy of Geriatric Cancer Research, Danish Cancer Society, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global health status / Quality of Life	Global health status will be described using EORTC QLQ-C30	12 months
Secondary	Health-related Quality of Life (HRQoL)	HRQoL is measured by EORTC QLQ-C30	12 months
Secondary	Health-related Quality of Life (HRQoL)	HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)	12 months
Secondary	Overall Survival	Overall Survival is measured from Geriatric 8 screening to time of death	12 months
Secondary	Cancer-specific Survival	Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer	12 months
Secondary	Adherence to initial oncologic treatment plan	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
Secondary	Adherence to initial oncologic treatment plan	Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.	12 months
Secondary	Adherence to initial oncologic treatment plan	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
Secondary	Performance analysis of the Geriatric 8	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