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Cancer in Nursing Home Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01910376
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Armonea
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief 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.


Condition or disease
Armonea Nursing Homes Residents

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910376


Locations
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Belgium
Armonea nursing homes network
Mechelen, Belgium
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Armonea
Investigators
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Study Chair: Hans Wildiers UZ Leuven, Belgium
More Information
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Additional Information:

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01910376    
Other Study ID Numbers: EORTC-1221
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019