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Cohort of Patients Over 70 Years of Age With Cancer and / or Hematological Malignancy (ChimioAge)
| Condition or disease | Intervention/treatment |
|---|---|
| Cancer and / or Hematological Malignancy | Other: Evaluation of the influence of geriatric factors |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cohort of Patients> 70 Years Old With Cancer and / or Hematological Malignancy Treated With Chemotherapy and / or Immunotherapy and / or Targeted Therapy and / or New Generation Hormone Therapy After Oncogeriatric Evaluation and Therapeutic Revision on Public Assistance -Hospitals From Marseille |
| Actual Study Start Date : | November 6, 2018 |
| Actual Primary Completion Date : | January 1, 2019 |
| Estimated Study Completion Date : | May 6, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
Other: 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.
|
- Geriatric Assessment (EGS) on Geriatric HDJ [ Time Frame: 3-6 moths ]Inclusion in HDJ and geriatric frailty collection (EGS) by the geriatrician in HDJ. Evaluation by pharmacist and collection in HDJ of the usual treatment, phytotherapy, future oncological treatment administered. Geriatric and pharmaceutical report in 24 hours sent to the treating physician and oncologist
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
| France | |
| Assistance Publique Hopitaux de Marseille | Recruiting |
| Marseille, France, 13354 | |
| Contact: Anne-Laure Couderc 04.91.74.45.30 anne-laure.couderc@ap-hm.fr | |
| Contact: Kahena AMICHI promotion.interne@ap-hm.fr | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 21, 2019 | ||||
| First Posted Date | May 23, 2019 | ||||
| Last Update Posted Date | May 23, 2019 | ||||
| Actual Study Start Date | November 6, 2018 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Geriatric Assessment (EGS) on Geriatric HDJ [ Time Frame: 3-6 moths ] Inclusion in HDJ and geriatric frailty collection (EGS) by the geriatrician in HDJ. Evaluation by pharmacist and collection in HDJ of the usual treatment, phytotherapy, future oncological treatment administered. Geriatric and pharmaceutical report in 24 hours sent to the treating physician and oncologist
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Cohort of Patients Over 70 Years of Age With Cancer and / or Hematological Malignancy | ||||
| Official Title | Cohort of Patients> 70 Years Old With Cancer and / or Hematological Malignancy Treated With Chemotherapy and / or Immunotherapy and / or Targeted Therapy and / or New Generation Hormone Therapy After Oncogeriatric Evaluation and Therapeutic Revision on Public Assistance -Hospitals From Marseille | ||||
| Brief Summary | 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 |
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 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. | ||||
| Condition | Cancer and / or Hematological Malignancy | ||||
| Intervention | Other: 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.
|
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| Study Groups/Cohorts | 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.
Intervention: Other: Evaluation of the influence of geriatric factors
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 6, 2024 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 70 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03960593 | ||||
| Other Study ID Numbers | 2018-56 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
| Study Sponsor | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | May 2019 | ||||
