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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Frailty, Cancer, Age

Intervention / Treatment
-----------------
* Other: Comprehensive Geriatric Assessment and follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 70 years Living in the region of Southern Denmark Newly diagnosed solid tumours assessed eligible for antineoplastic treatment Vulnerable or frail (G8 ≤ 14) Exclusion Criteria: Inability to speak or understand Danish Inability to give informed consent Already consulting geriatric outpatient clinic Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial with 2 randomized 1:1 parallel study groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care | Other: Comprehensive Geriatric Assessment and follow-up<br>* 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.<br>|
| No Intervention: Control<br>standard oncologic care according to national guidelines | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function for patients receiving palliative oncologic treatment | measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period. | 3 months | 
| unplanned hospital admissions for patients receiving adjuvant oncologic treatment | number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functional for patients receiving curative oncologic treatment | measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period. | 3 months | 
| Physical functional for patients receiving curative oncologic treatment | measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period. | 6 months | 
| Physical functional for patients receiving palliative oncologic treatment | measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period. | 6 months | 
| number of unplanned hospital admissions for patients receiving palliative oncologic treatment | Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records. | 6 months | 
| Health-related Quality of life | Measured by EORTC-QLQ-C30 | 12 months | 
| Health-related Quality of life | Measured by EORTC-QLQ-ELD14 | 12 months follow-up | 
| Elderly Functional Index Score (ELFI-score) | 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. | 6 months | 
| Number of patients who experience oncologic treatment toxicity | Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events | 6 months | 
| Number of patients with adherence to initial oncologic treatment plan | Registration of dose reductions, discontinuations and delays of intended cancer treatment. | 6 months | 
| Degree of Polypharmacy (PP) | Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs. | 3 months | 
| Number of potential Inappropriate Medications (PIM) | Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient | 3 months | 
| Number of Potential Drug Interactions (PDI) | Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient | 3 months | 
| Overall survival | Measured from Geriatric 8 screening to time of death | 12 months | 
| Cancer specific survival | Measured from Geriatric 8 screening to time of death in patients with residual cancer | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frailty, Aged, Neoplasms, Cancer Patients, Geriatric Screening, Geriatric 8, Geriatric Assessment, Randomized Clinical Trial