CancerEROGNCT03662061
Assessment of a Multidisciplinary Team Meeting (RCP) in Geriatric Oncology
An observational study of Cancer, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCP
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Sep 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
France2 sites
Oncologie radiothérapie - Hôpital Privé Jean Mermoz Ramsay Général de Santé Lyon
Lyon, 69008
Médecine Gériatrique/équipe mobile de gériatrie - Hôpital Edouard Herriot
Lyon, 69437
About this study
Official title: Analysis of the Specific Onco-geriatric Multidisciplinary Team Meeting (RCP) at E.Herriot Hospital (Hospices Civils de Lyon)
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).
Read more
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.
- Conditions
- Cancer
- Being tested
- Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCP
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCPOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start26 Sep 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662061
- Sponsor's protocol ID
- 69HCL17_0674
- Acronym
- EROG
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Specific Onco-geriatric Multidisciplinary Team Meeting (RCP) at E.Herriot Hospital (Hospices Civils de Lyon)
- ClinicalTrials.gov ID
- NCT03662061
- Acronym / sponsor ID
- EROG / 69HCL17_0674
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCPAfter 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. | Other | – |
Primary outcome
Proportion of patients whose recommendations' follow-up at 4 months after RCP, has been feasible.
Time frame: 4 months
Phone call 4 months after RCP to assess if recommendations have been followed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients whose recommendations' follow-up at 4 months after RCP, has been feasible. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.