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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03662061
Other study ID # 69HCL17_0674
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2018
Est. completion date July 30, 2019

Study information

Verified date September 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, cancer incidence increases over the course of life and therefore it is considered as an important pathology of the elderly. Cancers are the second leading cause of death for patients over 70 years old.

In 2015, 233,343 new cases of cancer were estimated for patients of 65 years and over (60.9% of estimated cancers of all ages), 42,547 new cases for older people over 85 years old (about 11% of all diagnosed cancer cases).

With the expected aging of the population in the coming years, the number of patients over the age of 70 will continue to increase. Life expectancy will also increase (12 years for the people above 75 years old and more than 8 years for the people above 80 years old).

The elderly are a heterogeneous population. Some people age well with few chronic diseases and a preserved autonomy. Others have several pathologies, geriatric syndromes (malnutrition, functional disorders, sensory deficits or psycho-cognitive diseases). Poly-medication is therefore common with an increased risk of iatrogenic disease. All these factors, in addition to social and economic conditions, determine the health status of the elderly. The presence of comorbidities decreases life expectancy and may itself be a contraindication to treatment. Patients in this age group are therefore particularly exposed to the risks of over- or under-treatment.

The multidisciplinary team meeting (RCP) is widely used for decision making in oncology. Various official texts govern it (Plan Cancer, HAS). However, the onco-geriatric decision is usually only a complementary opinion after a RCP of a specific organ.

Since 2006, the E. Herriot Hospital's Multidisciplinary team meeting has been organized to discuss cases of patients over 70 years old. The specificity is the association of a real multidisciplinary geriatric oncology discussion. The latter between medical specialist : geriatrician, oncologist, surgeon, radiotherapist, pharmacist, onco-geriatric nurse allows the development of an appropriate individualized therapeutic project for the patient.

The onco-geriatric multidisciplinary team is implementing a descriptive study of the RCP for the management of patients above 70 with cancer. The Regional Network of Oncology Auvergne-Rhône-Alpes is a partner.

The main aim is to describe the feasibility of the assessment of the follow-up of onco-geriatric recommendations 4 months after the onco-geriatric RCP of E. Herriot Hospital concerning patients with or with suspicion of cancer.

The secondary aims are : 1/ To describe the process of RCP: participants, patient's characteristics and conclusions with recommendations, 2/ To assess the implementation of oncological and geriatric recommendations 4 months after RCP 3/ To assess the survival, autonomy and quality of life of patients 4 months after RCP.

The hypothesis is that onco-geriatric RCP's recommendations improve the outcome for the patient.

The purpose of this pilot study is to ensure that the assessment of the recommendations' follow-up at 4 months is feasible.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 30, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Patients over 70 years

- with cancer or suspicion of cancer,

- with a systematic collection of oncological and geriatric data in their medical record submitted to the onco-geriatric RCP of E. Herriot hospital.

- Patients must be able to express their non-opposition to participate in this study or must be accompanied by a trustworthy person able to express his or her opposition.

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCP
After inclusion, patient's results are discussed at a weekly onco-geriatric multidisciplinary team meeting including surgeons, geriatrics, oncologists, radiotherapist, nurse, pharmacist. Oncological and geriatric recommendations are given. A phone call is made to the patient to evaluate the follow-up of the oncological and geriatric recommendations defined during the RCP along with their survival, autonomy and quality of life.

Locations

Country Name City State
France Médecine Gériatrique/équipe mobile de gériatrie - Hôpital Edouard Herriot Lyon
France Oncologie radiothérapie - Hôpital Privé Jean Mermoz Ramsay Général de Santé Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients whose recommendations' follow-up at 4 months after RCP, has been feasible. Phone call 4 months after RCP to assess if recommendations have been followed. 4 months
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