Cancer in Nursing Home Residents

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborator:
Armonea
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01910376
First received: July 24, 2013
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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
Armonea Nursing Homes Residents

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 825
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910376

Contacts
Contact: Nicolas Dif, PhD +32 2 774 10 43 nicolas.dif@eortc.be

Locations
Belgium
Armonea nursing homes network Not yet recruiting
Mechelen, Belgium
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Armonea
Investigators
Study Chair: Hans Wildiers UZ Leuven, Belgium
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01910376     History of Changes
Other Study ID Numbers: EORTC 1221
Study First Received: July 24, 2013
Last Updated: July 25, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014