Geriatric Oncology Screening of Older Patients With Solid Cancers

Completed

• Conditions: Cancer; Screening; Solid Carcinoma; Geriatrics; Frailty; Age
• Interventions: Diagnostic Test: Geriatric 8; Diagnostic Test: modified Geriatric 8; Diagnostic Test: 30 second chair stand test; Diagnostic Test: Handgrip Strength Test

• Registration Number: NCT04644874
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-03
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-25
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1401

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older cancer patients	Geriatric 8	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,
Older cancer patients	modified Geriatric 8	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,
Older cancer patients	30 second chair stand test	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,
Older cancer patients	Handgrip Strength Test	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,

Primary Outcome Measures

Name	Time	Method
Global health status / Quality of Life	12 months	Global health status will be described using EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months	Overall Survival is measured from Geriatric 8 screening to time of death
Performance analysis of the Geriatric 8	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).
Health-related Quality of Life (HRQoL)	12 months	HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)
Adherence to initial oncologic treatment plan	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.
Cancer-specific Survival	12 months	Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Fyn, Denmark