CClinicalTrials.gg
CompletedNCT01910376Updated Mar 13, 2019

Cancer in Nursing Home Residents

An observational study in Armonea Nursing Homes Residents, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 1 site in Belgium. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
125
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Armonea Nursing Homes Residents
03

In context

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents (≥ 65 years) in a nursing home in the Armonea network in Belgium.

Inclusion criteria

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.

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.

Exclusion criteria

Exclusion criteria:

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
125 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.

    Time frame: 2 years

07

Study locations

1 site
  • Armonea nursing homes network
    Mechelen, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01910376
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Armonea
Responsible party
Sponsor
First posted
Jul 29, 2013
Start date
Oct 2014
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Mar 13, 2019

Study contacts

Hans Wildiers
study chair · UZ Leuven, Belgium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion