Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials. The objective of this project is to develop a set of geriatric data, the Geriatric Core Dataset (G-CODE), to be collected in cancer trials of older patients. The methods rely on a consensus process involving international experts in the field of oncology and geriatrics.

Detailed Description
-----------------
Although cancer is prevalent in the older segment of the population, older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. As a result, robust data on the benefit/risk balance are lacking for many treatment strategies in these patients. Ageing is a heterogeneous process that stresses the clinical need to identify comorbid conditions and ageing-related physiologic changes, both well-known factors increasing the risk of treatment side-effects and poor outcomes. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials. In 2011, after a workshop on clinical trial methodology in older adults with cancer, the Elderly Task Force of the European Organization for Research and Treatment of Cancer (EORTC) recommended the use of a standardised minimum data set (minDS) for assessing the global health and functional status of older populations. This minDS consisted of the G8 screening tool, the Instrumental Activities of Daily Living Following a consensus approach, a panel of 14 geriatricians from oncology clinics identified seven domains of importance in geriatric assessment. Based on the international recommendations, geriatricians selected the mostly commonly used tools/items for geriatric assessment by domain. The Geriatric Core Dataset (G-CODE) was progressively developed according to RAND appropriateness ratings and feedback during three successive Delphi rounds. The face validity of the G-CODE was assessed with two large panels of health professionals (55 national and 42 international experts) involved both in clinical practice and cancer trials.

Official Title
-----------------
Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists) clinical research associates nurses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly cancer patients included in randomized controlled trials<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Experts Who Considered That the Question Do You Live Alone ? Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Question do You Have a Person or Caregiver Able to Provide Care and Support Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Tool ADL (Activities of Daily Living) Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Tool 4-IADL (Instrumental Activities of Daily Living) Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Test Timed Up and Go Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Items Weight Loss During the Past 6 Months and Body Mass Index (BMI) Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Item One Cognitive Scale (Mini-Cog) Should be Retained in the G-CODE |  | Day 1 | 
| Number of Experts Who Considered That the Item Char Lson Comorbidity Index Should be Retained in the G-CODE |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, elderly, randomized trial, consensus