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Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

NCT ID: NCT02025062

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Head and Neck Squamous Cell Carcinomas (HNSCCs)

Keywords

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head and neck squamous cell carcinomas (HNSCCs) elderly cancer comprehensive geriatric assessment functional status malnutrition survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

CGA and geriatric follow-up

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Cancéropole Ile De France

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eléna Paillaud, MD / PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Lydia Brugel, MD / PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier intercommunal de Créteil

Locations

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Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor

Créteil, , France

Site Status

Countries

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France

References

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Abstracts of the 6th European Congress of Oto-Rhino-Laryngology Head and Neck Surgery, June 30-July 4, 2007, Vienna, Austria. Eur Arch Otorhinolaryngol. 2007 Jun;264 Suppl 1:S1-354. doi: 10.1007/s00405-007-0343-8. No abstract available.

Reference Type BACKGROUND
PMID: 17558509 (View on PubMed)

Homma A, Sakashita T, Oridate N, Suzuki F, Suzuki S, Hatakeyama H, Mizumachi T, Taki S, Fukuda S. Importance of comorbidity in hypopharyngeal cancer. Head Neck. 2010 Feb;32(2):148-53. doi: 10.1002/hed.21158.

Reference Type BACKGROUND
PMID: 19536763 (View on PubMed)

Lafont C, Paillaud E, Bertolus C, Baron M, Caillet P, Bouvard E, Laurent M, Salvan D, Chaumette L, de Decker L, Piot B, Barry B, Raynaud-Simon A, Sauvaget E, Minard A, Anota A, Panjo H, Brugel L, Canoui-Poitrine F. Geriatric assessment and quality of life for 2 years in older patients with head and neck cancer. J Natl Cancer Inst. 2024 May 8;116(5):758-763. doi: 10.1093/jnci/djae027.

Reference Type DERIVED
PMID: 38335935 (View on PubMed)

Brugel L, Laurent M, Caillet P, Radenne A, Durand-Zaleski I, Martin M, Baron M, de Kermadec H, Bastuji-Garin S, Canoui-Poitrine F, Paillaud E. Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR). BMC Cancer. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427.

Reference Type DERIVED
PMID: 24923533 (View on PubMed)

Other Identifiers

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2013-A00437-38

Identifier Type: OTHER

Identifier Source: secondary_id

K120902

Identifier Type: -

Identifier Source: org_study_id