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Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients (EGéSOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025062
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancéropole Ile De France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinomas (HNSCCs) Other: CGA and geriatric follow-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
No Intervention: Control
In the control arm, patients are followed-up by the head-and-neck physician, oncologist and radiotherapists and did not benefit of Comprehensive Geriatric Assessment.
Experimental: Comprehensive Geriatric Assessment
The CGA (Comprehensive Geriatric Assessment) 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.
Other: CGA and geriatric follow-up
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




Primary Outcome Measures :
  1. Composite criteria, including: death; autonomy (if loss of two points or more in the Activity of Daily Living (ADL) compared with the initial ADL); nutritional status (if weight loss of 10% or more compared to the initial weight at diagnosis [ Time Frame: 6 months after the randomization ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 6 month, 12 month and 24 month after the randomization ]
  2. death [ Time Frame: 6 month , 12 month and 24 month after the randomization ]
  3. total duration of hospitalization [ Time Frame: 6 month, 12 month and 24 month after the randomization ]
  4. quality of life (QLQC30, HN35) [ Time Frame: 6 month , 12 month and 24 month after the randomization ]
  5. costs of treatment [ Time Frame: 6 month , 12 month and 24 month after the randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 65 years old and over (modified by amendment n 2 -1/07/2014)
  • macroscopical lesions suggesting an cancerous tumor in head and neck awaiting pathology confirmation;
  • support in one of ENT/Maxilla-facial surgery departments in the study;
  • patients insured by a social security;
  • patients informed of the study, and having given his non opposition verbally.

Exclusion Criteria:

  • patients deprived of liberty or under legal protection;
  • presence of psychological, family, socials or geographic condition(s) that may interfere with the proper conduct of the study;
  • personal history of head and neck cancer except single surgery for squamos cell carcinoma without additional treatment (without curietherapy or RT) with a free interval of at least 5 years (modified by amendment n 2 -1/07/2014)
  • patients with cancerous tumor of sinus and salivary glands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025062


Contacts
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Contact: Eléna Paillaud, MD / PhD (0)1 49 81 30 74 ext +33 elena.paillaud@aphp.fr
Contact: Lydia Brugel, MD (0)1 49 81 30 74 ext +33 lydia.brugel@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor Recruiting
Créteil, France, 94000
Contact: Aroua ZRIBI, M.Sc    (0)1 49 81 47 87 ext +33    aroua.zribi@aphp.fr   
Contact: Laetitia Gregoire, M.Sc    (0)1 49 81 41 64 ext +33    laetitia.gregoire@aphp.fr   
Principal Investigator: Eléna Paillaud, MD / PhD         
Principal Investigator: Lydia Brugel, MD / PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute (NCI)
Cancéropole Ile De France
Investigators
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Principal Investigator: Eléna Paillaud, MD / PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Lydia Brugel, MD / PhD Centre Hospitalier Intercommunal de Créteil

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02025062    
Other Study ID Numbers: K120902
2013-A00437-38 ( Other Identifier: NCI )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
head and neck squamous cell carcinomas (HNSCCs)
elderly
cancer
comprehensive geriatric assessment
functional status
malnutrition
survival
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site