Clinical trial NCT03976531: Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients
Official title: Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: cancer
elderly
randomized trial
consensus
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Plate-forme PACAN (Elderly and Cancer Platform)
name: European Georges Pompidou Hospital
name: Hospital Ambroise Paré Paris
name: Institut Curie
name: Centre Leon Berard
name: Institut Claudius Regaud
name: Saint-Louis Hospital, Paris, France
name: Hospital Avicenne
name: Göteborg University
name: Oslo University Hospital
name: City of Hope Comprehensive Cancer Center
First posted: 2019-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The panel of experts (cancer specialists, clinical research associates, nurses) was in charge of assessing the the relevance and approppriateness of the selected tools to include in the Geriatric Core Data Set (G-Code).

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.

Eligibility criteria: * cancer specialists (medical oncologists, surgeons, radiation oncologists, geriatricians, disease-oriented oncologists, clinical oncologists)
* clinical research associates
* nurses.

Primary outcomes:
measure: Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE
timeFrame: Day 1
measure: Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE
timeFrame: Day 1
measure: Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE
timeFrame: Day 1
measure: Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié, Comprehensive Cancer Center
Study officials:
affiliation: Institut Bergonié
name: Simone Mathoulin-Pélissier, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paillaud E, Soubeyran P, Caillet P, Cudennec T, Brain E, Terret C, Etchepare F, Mourey L, Aparicio T, Pamoukdjian F, Audisio RA, Rostoft S, Hurria A, Bellera C, Mathoulin-Pelissier S; G-CODE collaborators. Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey. Eur J Cancer. 2018 Nov;103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.