Cohort of Patients Over 70 Years of Age With Cancer and / or Hematological Malignancy

NCT ID: NCT03960593

Last Updated: 2019-05-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2024-05-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Follow-up of patients\> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions. We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients\> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aging of the French population is associated with a constant increase in the number of cancers in people over 75 years of age (1/3 of cancers diagnosed in patients ≥ 75 years).

Oncogeriatrics is a combination of two specialties, oncology and geriatrics. This practice aims to ensure that all elderly cancer patients are treated according to their condition through a multidisciplinary and multiprofessional approach. The improvement of the care of elderly people with cancer has been measured in Measure 23.4 of the 2009-2013 Cancer Plan. This objective is pursued through action 2.16 of the 2014-2019 Cancer Plan aimed at meeting the specific needs of elderly people with cancer, notably by relying on the organizational set-up of UCOGs (Coordination Units in Onco-Geriatrics). for an improvement of the management practices of this population and a structuring of clinical research in oncogeriatrics.

However, 85% of people over 75 have at least one pathology and more than 7 different molecules are delivered on average at least three times a year. Polypharmacy is a factor of frailty and the risk of functional decline is established from two prescribed drugs. Polypharmacy can be problematic in elderly patients with cancer who are treated with chemotherapy.

In our institution, we wanted to combine a review of therapies with this geriatric evaluation in elderly patients with cancer or haematological diseases managed by a systemic oncological treatment. In this context, during the evaluation sessions in day hospital (HDJ) of oncogeriatrics on the Assistance Publique-Hopitaux de Marseille (AP-HM), a medical assessment and a cross analysis between the usual treatments of patients (herbal medicine) and self-medication) and chemotherapy and / or immunotherapy and / or targeted therapy and / or new generation hormone therapy are routinely performed. The main objective of this work is to evaluate the influence of the therapeutic revisions associated with the EGS data on the unplanned hospitalization rate at 3 months and then the secondary objective of the impact on the course of treatment oncology, to become patients and their survival. For this purpose, we want to conduct a pilot observational cohort study, monocentric, prospective, descriptive for patients convened in oncogeriatric HDJ and each patient is followed for 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer and / or Hematological Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with cancer and / or hematological

The population of the study will be all patients over 70 years of age with oncogeriatric HDJ cancer prior to initiation of oncologic therapy such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or hormone therapy. new generation.

Evaluation of the influence of geriatric factors

Intervention Type OTHER

Follow-up of patients\> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions. We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients\> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation of the influence of geriatric factors

Follow-up of patients\> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions. We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients\> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects over the age of 70 with an Oncoding score less than or equal to 14
* Patients receiving social security benefits
* suffering from cancerous pathology whatever the stage / grade and the associated comorbidities treated by chemotherapy and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy
* Having read, understood and signed the non-opposition form

Exclusion Criteria

* Patients refusing to participate in the research project
* Patients under guardianship or curatorship
* Patients who are not beneficiaries of a social security scheme
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne-Laure Couderc

Role: primary

04.91.74.45.30

Kahena AMICHI

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Couderc AL, Ninove L, Nouguerede E, Rey D, Rebroin M, Daumas A, Tomasini P, Greillier L, Salas S, Duffaud F, Dahan L, Duluc M, Garcia ME, Pluvy J, Chaleat S, Farnault L, Venton G, Fourie T, Nurtop E, de Lamballerie X, Villani P, Charrel R, Correard F. Acceptance, efficacy, and safety of COVID-19 vaccination in older patients with cancer. J Geriatr Oncol. 2022 Jul;13(6):850-855. doi: 10.1016/j.jgo.2022.05.002. Epub 2022 May 16.

Reference Type DERIVED
PMID: 35589542 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-56

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.