Cancer
Conditions
Keywords
cancer, elderly, randomized trial, consensus
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.
Interventions
None listed
Sponsors
Plate-forme PACAN (Elderly and Cancer Platform)
European Georges Pompidou Hospital
Hospital Ambroise Paré Paris
Institut Curie
Centre Leon Berard
Institut Claudius Regaud
Saint-Louis Hospital, Paris, France
Hospital Avicenne
Göteborg University
Oslo University Hospital
City of Hope Comprehensive Cancer Center
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists) * clinical research associates * nurses.
Design outcomes
Primary
| Measure | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| National Panel of Experts National panel of experts involved in the scoring of the items/tools to be included in the G-CODE. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | National Panel of Experts |
|---|---|
| Age, Customized >= 18 years | 42 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Number of Experts Who Considered That the Item Char Lson Comorbidity Index Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Item Char Lson Comorbidity Index Should be Retained in the G-CODE | 42 Participants |
Primary
Number of Experts Who Considered That the Item One Cognitive Scale (Mini-Cog) Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Item One Cognitive Scale (Mini-Cog) Should be Retained in the G-CODE | 42 Participants |
Primary
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
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | 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 | 42 Participants |
Primary
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
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | 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 | 42 Participants |
Primary
Number of Experts Who Considered That the Question Do You Live Alone ? Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Question Do You Live Alone ? Should be Retained in the G-CODE | 42 Participants |
Primary
Number of Experts Who Considered That the Test Timed Up and Go Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Test Timed Up and Go Should be Retained in the G-CODE | 42 Participants |
Primary
Number of Experts Who Considered That the Tool 4-IADL (Instrumental Activities of Daily Living) Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Tool 4-IADL (Instrumental Activities of Daily Living) Should be Retained in the G-CODE | 42 Participants |
Primary
Number of Experts Who Considered That the Tool ADL (Activities of Daily Living) Should be Retained in the G-CODE
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| National Panel of Experts | Number of Experts Who Considered That the Tool ADL (Activities of Daily Living) Should be Retained in the G-CODE | 42 Participants |