Armonea Nursing Homes ResidentsNCT01910376
Cancer in Nursing Home Residents
An observational study of Armonea Nursing Homes Residents, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
Trial summary
Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality occurs in people older than 65 years. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Armonea Nursing Homes Residents
- How many people
- 125 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Dec 2017
- How long will I take part?
- 2 Years
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Residents (≥ 65 years) in a nursing home in the Armonea network in Belgium.
Who may be able to join
- All individuals:
- Age ≥ 65 years
- Residents in a nursing home in the Armonea network in Belgium.
- Absence of any psychological, familial, or sociological condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient/proxy before registration in the study.
- Written informed consent must be given according to ICH/GCP, and national/local regulations.
- The treating general practitioner (GP) is willing to provide medical information required by the study.
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- Cancer patient cohort:
- Patients must have a new cancer event defined as one of:
- A strong clinical suspicion (based on physician's judgement) of a new cancer where a diagnostic or therapeutic decision needs to be taken.
- A strong clinical suspicion (based on physician's judgement) of progression of a previously known cancer where a diagnostic or therapeutic decision needs to be taken.
- Diagnosis of a new cancer where a diagnostic or therapeutic decision needs to be taken.
- Diagnosis of progression of a previously known cancer where a diagnostic or therapeutic decision needs to be taken.
- All invasive cancer types and all histologies are eligible. All lines of treatment are eligible. Patients who are diagnosed with cancer during routine medical examinations for some other medical condition
- Control cohort:
- Absence of known active invasive cancer, or strong clinical suspicion of cancer (based on physician's judgement) at baseline.
Who cannot join
- Patients who were not suspected to have cancer (progression) in the nursing home, but are hospitalized for other (medical) reasons, are then diagnosed with cancer during hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer in Elderly Nursing Home Residents in Belgium: Prospective Cohort Study Including Translational Research to Develop Better Prognostic Tools to Help With Treatment Decisions in the Elderly
Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality occurs in people older than 65 years. Moreover, due to the aging of the population in the Western world the number of elderly people is expected to increase and therefore the number of older cancer patients is expected to rise. Despite this rapid increase in cancer incidence and cancer-related mortality with age, our knowledge about ageing and cancer and about optimal treatment for older cancer patients is still far from adequate. Therefore, it is clear that cancer in the elderly is a major and increasing health problem. A key problem in geriatric oncology research is the important selection bias because very old/frail patients, are very rarely included in clinical trials.
Changes in the patterns of health care delivery have shifted the care of the elderly from acute care settings to the community and long-term care facilities. As the European population ages, more and more people will become nursing home residents, many of whom will have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer is very common in elderly nursing home residents, it is poorly studied. This lack of information may impact on clinical decision making and the appropriateness of treatments offered and therefore collection of this information is needed.
This project has two main objectives. The first objective is to report on demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome of patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken. The second objective is to develop better prognostic tools (for survival) including biological markers of ageing to help treatment decisions in the elderly.
- Conditions
- Armonea Nursing Homes Residents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | Nursing home residents without cancer | |
| Cancer patient cohort | Patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken | |
| Biomarker cohort | Subgroup of individuals in the control cohort willing to provide a blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic capacity of p16INK4a expression in T lymphocytes on Overall Survival
Measured: The analyses will be performed when 90 deaths will have been observed
Demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome in nursing home patients with cancer or with strong clinical suspicion of cancer.
Measured: Baseline, every 3 months and for max. 2 years
Secondary outcomes (3)
Comparison of baseline parameters and outcome between nursing home cancer patients (cancer patient cohort) and nursing home non-cancer patients (control cohort)
Measured: Baseline, every 3 months and for max. 2 years
Prognostic capacity of baseline clinical markers and Porock scale on OS, functional decline, cognitive decline and Quality of Life separately in nursing home cancer group (cancer patient cohort) and non-cancer group (control cohort).
Measured: Baseline, every 3 months and for max. 2 years
Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Armonea Nursing Homes ResidentsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Armonea
- Responsible party
- Sponsor
- Investigators
- Hans Wildiers, Study chair, UZ Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910376
- Sponsor's protocol ID
- EORTC-1221
- Status last verified
- Mar 2019
- First submitted
- 24 Jul 2013
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer in Elderly Nursing Home Residents in Belgium: Prospective Cohort Study Including Translational Research to Develop Better Prognostic Tools to Help With Treatment Decisions in the Elderly
- ClinicalTrials.gov ID
- NCT01910376
- Acronym / sponsor ID
- EORTC-1221
- Conditions
- Armonea Nursing Homes Residents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Armonea
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Jul 2013 (estimated)
- 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.
Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality occurs in people older than 65 years. Moreover, due to the aging of the population in the Western world the number of elderly people is expected to increase and therefore the number of older cancer patients is expected to rise. Despite this rapid increase in cancer incidence and cancer-related mortality with age, our knowledge about ageing and cancer and about optimal treatment for older cancer patients is still far from adequate. Therefore, it is clear that cancer in the elderly is a major and increasing health problem. A key problem in geriatric oncology research is the important selection bias because very old/frail patients, are very rarely included in clinical trials.
Changes in the patterns of health care delivery have shifted the care of the elderly from acute care settings to the community and long-term care facilities. As the European population ages, more and more people will become nursing home residents, many of whom will have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer is very common in elderly nursing home residents, it is poorly studied. This lack of information may impact on clinical decision making and the appropriateness of treatments offered and therefore collection of this information is needed.
This project has two main objectives. The first objective is to report on demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome of patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken. The second objective is to develop better prognostic tools (for survival) including biological markers of ageing to help treatment decisions in the elderly.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | –Nursing home residents without cancer |
| Cancer patient cohort | – | –Patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken |
| Biomarker cohort | – | –Subgroup of individuals in the control cohort willing to provide a blood sample |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Residents (≥ 65 years) in a nursing home in the Armonea network in Belgium.
Key inclusion criteria (15 listed)
- Age ≥ 65 years
- Residents in a nursing home in the Armonea network in Belgium.
- Absence of any psychological, familial, or sociological condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient/proxy before registration in the study.
- Written informed consent must be given according to ICH/GCP, and national/local regulations.
- The treating general practitioner (GP) is willing to provide medical information required by the study.
Key exclusion criteria (1 listed)
- Patients who were not suspected to have cancer (progression) in the nursing home, but are hospitalized for other (medical) reasons, are then diagnosed with cancer during hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic capacity of p16INK4a expression in T lymphocytes on Overall Survival
Time frame: The analyses will be performed when 90 deaths will have been observed
Demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome in nursing home patients with cancer or with strong clinical suspicion of cancer.
Time frame: Baseline, every 3 months and for max. 2 years
3 secondary outcomes
Comparison of baseline parameters and outcome between nursing home cancer patients (cancer patient cohort) and nursing home non-cancer patients (control cohort)
Time frame: Baseline, every 3 months and for max. 2 years
Prognostic capacity of baseline clinical markers and Porock scale on OS, functional decline, cognitive decline and Quality of Life separately in nursing home cancer group (cancer patient cohort) and non-cancer group (control cohort).
Time frame: Baseline, every 3 months and for max. 2 years
Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.
Time frame: 2 years
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 13 Mar 2019.
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.
Hans Wildiers study chair
UZ Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Armonea Nursing Homes Residents, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
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 15 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 13 Mar 2019. 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 Belgium. 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?
Prognostic capacity of p16INK4a expression in T lymphocytes on Overall Survival (time frame: The analyses will be performed when 90 deaths will have been observed). The study lists 2 primary outcomes in all. 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 13 Mar 2019.