CancerONCO-EHPADNCT03103659
Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration
A study testing personalised care plan in people with Cancer and Elderly, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
According to data from the French National Cancer Institute (INCA), almost one third of the cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients management is an important part in oncology daily practice. Read more about this study
- Who is it for?
- Ages 75 years and older
- What is being tested?
- personalised care plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2017to 27 Apr 2019
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients with new diagnosis of cancer or follow-up breakdown or progression of the cancer disease
Who cannot join
- Elderly patients with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Anne-Laure COUDERC, MD contact
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Anne-Laure COUDERC, MD
About this study
According to data from the French National Cancer Institute (INCA), almost one third of the cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients management is an important part in oncology daily practice.
These last years, through the geriatric oncology development, collaboration between oncologists and geriatricians, the anti-cancer management and supportive care for elderly patients has evolved. The assessement of potential fragility helps to determine the cancers appropriate treatment plan.
Read more
Studies have shown that alterations in geriatric fields, found through Comprehensive Geriatric Assessment (CGA) are associated with poorer survival, increased risk of chemotherapy severe toxicity and autonomy loss.
Nursing home residents have often more frailties and functional problems than living at home elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home residents must have appropriate treatment to preserve as much as possible their quality of life.
Transversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille hospital propose to organize a personalized care course for nursing home residents with cancer to minimize the diagnostics delay, facilitate their management in oncology and maintain their quality of life.
Elderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological and geriatric assessment. Patient would be supported by UTOG and would have access to technical platform.
According to his cancer and nursing home location, the nearest reference center would be offered.
Treatment or course of action (monitoring, palliative care …) would be decided in onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit UCOG PACA west) and programmed and fast hospitalization would be organized in the reference center.
When returning in nursing homes, elderly patient would be revalued by EMGE to continue therapeutic management and personalized care plan. The aim of this management is to allow a shorter hospitalization and maintain the quality of life of frailty patient during cancer treatment.
- Being tested
- personalised care plan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalised care planOther
Quality of life assessement in elderly cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Elderly patient with cancer living in a nursing home | Experimental | Not described Receives: Other: personalised care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time frame between diagnosis and access to oncologies care facilities
Number of days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start27 Apr 2017 (estimated)
- Primary completion27 Apr 2018 (estimated)
- Study completion27 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103659
- Sponsor's protocol ID
- 2016-48
- Acronym
- ONCO-EHPAD
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Couderc AL, Berbis J, Delalande G, Mugnier B, Courcier A, Bourriquen M, Rey D, Greillier L, Baciuchka M, Sudour P, Agnelli L, Nouguerede E, Fabries S, Villani P. Impact of care pathway for nursing home residents treated for cancer: ONCO-EHPAD study. Support Care Cancer. 2021 Jul;29(7):3933-3942. doi: 10.1007/s00520-020-05973-1. Epub 2021 Jan 3.
PubMed 33392770
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration
- ClinicalTrials.gov ID
- NCT03103659
- Acronym / sponsor ID
- ONCO-EHPAD / 2016-48
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 Apr 2017 (estimated)
- Primary completion
- 27 Apr 2018 (estimated)
- Study completion
- 27 Apr 2019 (estimated)
- First posted
- 6 Apr 2017 (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.
According to data from the French National Cancer Institute (INCA), almost one third of the cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients management is an important part in oncology daily practice.
These last years, through the geriatric oncology development, collaboration between oncologists and geriatricians, the anti-cancer management and supportive care for elderly patients has evolved. The assessement of potential fragility helps to determine the cancers appropriate treatment plan.
Studies have shown that alterations in geriatric fields, found through Comprehensive Geriatric Assessment (CGA) are associated with poorer survival, increased risk of chemotherapy severe toxicity and autonomy loss.
Nursing home residents have often more frailties and functional problems than living at home elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home residents must have appropriate treatment to preserve as much as possible their quality of life.
Transversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille hospital propose to organize a personalized care course for nursing home residents with cancer to minimize the diagnostics delay, facilitate their management in oncology and maintain their quality of life.
Elderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological and geriatric assessment. Patient would be supported by UTOG and would have access to technical platform.
According to his cancer and nursing home location, the nearest reference center would be offered.
Treatment or course of action (monitoring, palliative care …) would be decided in onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit UCOG PACA west) and programmed and fast hospitalization would be organized in the reference center.
When returning in nursing homes, elderly patient would be revalued by EMGE to continue therapeutic management and personalized care plan. The aim of this management is to allow a shorter hospitalization and maintain the quality of life of frailty patient during cancer treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patient with cancer living in a nursing home | Experimental | Other: personalised care plan |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly patients with new diagnosis of cancer or follow-up breakdown or progression of the cancer disease
Key exclusion criteria (1 listed)
- Elderly patients with cognitive impairment.
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 |
|---|---|---|
| personalised care planQuality of life assessement in elderly cancer patients | Other | Elderly patient with cancer living in a nursing home |
Primary outcome
Time frame between diagnosis and access to oncologies care facilities
Time frame: 6 months
Number of days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 33392770Couderc AL, Berbis J, Delalande G, Mugnier B, Courcier A, Bourriquen M, Rey D, Greillier L, Baciuchka M, Sudour P, Agnelli L, Nouguerede E, Fabries S, Villani P. Impact of care pathway for nursing home residents treated for cancer: ONCO-EHPAD study. Support Care Cancer. 2021 Jul;29(7):3933-3942. doi: 10.1007/s00520-020-05973-1. Epub 2021 Jan 3.
- 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.
Anne-Laure COUDERC, MD contact
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalised care plan in people with Cancer and Elderly, run by Assistance Publique Hopitaux De Marseille at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Laure COUDERC, MD (anne-laure.couderc@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time frame between diagnosis and access to oncologies care facilities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103659, which also lists 1 linked publication.
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 6 Apr 2017.