N/A
N=42
Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03976531 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE — 42 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE |
42 | — |
| 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 |
42 | — |
| PRIMARY Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE |
42 | — |
| PRIMARY Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE |
42 | — |
| PRIMARY Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE |
42 | — |
| 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 |
42 | — |
| PRIMARY Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE |
42 | — |
| PRIMARY Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE |
42 | — |
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.
Eligibility Criteria
- cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists)
- clinical research associates
- nurses.
Data sourced from ClinicalTrials.gov (NCT03976531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.