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Spots Global Cancer Trial Database for Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

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Trial Identification

Brief Title: Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

Official Title: 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

Study ID: NCT02025062

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor, Créteil, , France

Contact Details

Name: Eléna Paillaud, MD / PhD

Affiliation: Assistance Publique - Hôpitaux de Paris

Role: PRINCIPAL_INVESTIGATOR

Name: Lydia Brugel, MD / PhD

Affiliation: Centre Hospitalier intercommunal de Créteil

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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