Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Frailty

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,

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.

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.

modified Geriatric 8

30 second chair stand test

Handgrip Strength Test

Marianne Ewertz, MD, DMSc

Jesper Ryg, MD, PhD

Cecilia M Lund, MD, PhD

Trine L Jørgensen, MD, PhD

Per Pfieffer, MD, PhD

Henrik J Ditzel, MD, DMSc

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.

Geriatric Oncology Screening of Older Patients With Solid Cancers

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

Global health status will be described using EORTC QLQ-C30

HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)

Overall Survival is measured from Geriatric 8 screening to time of death

Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer

Deviation from initial oncologic treatment plan with the registration of dose reductions, with the given dose measured as a percentage of the planned dose.

Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.

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.

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).

Academy of Geriatric Cancer Research

Danish Cancer Society

University of Southern Denmark

Odense University Hospital

Principal Investigator

Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care

standard oncologic care according to national guidelines

All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.

Follow-up on initial treatment plan is scheduled to one month after baseline CGA.

Comprehensive Geriatric Assessment and follow-up

Jesper Ryg, MD

Jesper Ryg, MD, Prof.

Ann-Kristine W Giger, MD

Per Pfeiffer, MD, PhD

Henrik Ditzel, MD, DMSc

A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.

This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.

Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.

Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.

Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.

The randomized groups will be compared with respect to primary and secondary endpoints.

Randomized Clinical Trial with 2 randomized 1:1 parallel study groups

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)

measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.

number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.

Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.

Self reported functioning score. It is a composite score derived from the three scales "physical functioning", "Role functioning" and Social Functioning", from the quality of life questionnaire EORTC-QLQ-C30 and the scale "Mobility" from the quality of life questionnaire EORTC-QLQ-ELD-14. The range is (12-48), with a higher score being a better outcome.

Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events

Registration of dose reductions, discontinuations and delays of intended cancer treatment.

Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.

Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient

Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient

Measured from Geriatric 8 screening to time of death

Measured from Geriatric 8 screening to time of death in patients with residual cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Geriatric Oncology Screening of Older Patients With Solid Cancers	NCT04644874	Solid Carcinoma Frailty Age Geriatrics Screening Cancer	Geriatric 8 modified Geriat... 30 second chair... Handgrip Streng...	70 Years -	Odense University Hospital
Geriatric Oncology Screening of Older Patients With Solid Cancers	NCT04644874	Solid Carcinoma Frailty Age Geriatrics Screening Cancer	Geriatric 8 modified Geriat... 30 second chair... Handgrip Streng...	70 Years -	Odense University Hospital
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers	NCT04686851	Frailty Cancer Age	Comprehensive G...	70 Years -	Odense University Hospital

Spots Global Cancer Trial Database for geriatric screening