Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor
Créteil, 94000, France
NCT Number: NCT02025062
The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological management, nutritional and functional status, and support needed at home. To assess the overall needs of the elderly patients, an assessment known as "comprehensive geriatric assessment" (CGA) can be performed by a geriatrician with extensive testing and questionnaires. This assessment is long and requires an experienced geriatrician. It leads to the development of an individualized treatment plan (physiotherapy, psychological follow-up, support at home, nutritional management ...) and follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA utility has been studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed improving survival and maintaining the elderly at home.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Créteil, 94000, France
Context: The survival of elderly patients with head and neck squamous cell carcinomas (HNSCC) cancer is greatly reduced compared to younger subjects. Several explanations have been proposed : a competitive comorbidity, a more frequent refusal of standard therapy or the choice of a suboptimal treatment due to fear of toxicities. The comprehensive geriatric assessment (CGA) may influence the decision-making process and help for managing elderly patients with head and neck cancer. The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.
Hypotheses: We postulate that the CGA and the geriatric follow-up improves 1) the therapeutic decision-making process thanks to a better assessment of the patient's functional reserve and its capacity to support or not the treatment, and 2) the overall survival, the functional status and the nutritional status of elderly patients with HNSCC because of a more appropriate treatment and a personalized medical follow-up after surgery and/or radiotherapy and/or chemotherapy or more rarely targeted therapy, with adjustment of treatments and management of comorbidities and/or treatment complications.
Main objective: To assess the impact of the CGA and the geriatric follow-up on the overall survival, the functional status and the nutritional status of elderly patients with HNSCC.
Secondary objectives: To assess the impact of the CGA on the therapeutic decision, the toxicity and/or complications of treatment, the complete realization of treatment, the autonomy, the institutionalization, the total hospitalization stay, the quality of life of elderly patients with HNSCCs and the costs.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up
Time frame: 6 months after the randomization
Time frame: 6 month, 12 month and 24 month after the randomization
Time frame: 6 month , 12 month and 24 month after the randomization
Time frame: 6 month, 12 month and 24 month after the randomization
Time frame: 6 month , 12 month and 24 month after the randomization
Time frame: 6 month , 12 month and 24 month after the randomization
Assistance Publique - Hôpitaux de Paris
Other
Impact of Comprehensive Geriatric Assessment on Malnutrition, Functional Status and Survival in Elderly Patients With Head and Neck Squamous Cell Carcinomas (HNSCCs): a Randomized Controlled Multicenter Clinical Trial
Acronym: EGéSOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07167082
Atrophy, Body Weight
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial DetailsNCT07558486
Atrophy, Childhood Cancer
Jimma, Ethiopia
View Trial DetailsNCT06998030
Aged, Blood Protein Disorders
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial DetailsNCT06902402
Cancer, Malnutrition
Keelung, Taiwan
View Trial Details