NCT03662061

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 5, 2018

Last Update Submit

September 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study concerns patients above 70 years with cancer or suspicion of cancer who benefit from an onco-geriatric case analysis by the multidisciplinary team meeting (RCP).

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oncologie radiothérapie - Hôpital Privé Jean Mermoz Ramsay Général de Santé Lyon

Lyon, 69008, France

Location

Médecine Gériatrique/équipe mobile de gériatrie - Hôpital Edouard Herriot

Lyon, 69437, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

September 26, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations