Cancer in Nursing Home Residents

NCT ID: NCT01910376

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Armonea Nursing Homes Residents

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control cohort

Nursing home residents without cancer

No interventions assigned to this group

Cancer patient cohort

Patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken

No interventions assigned to this group

Biomarker cohort

Subgroup of individuals in the control cohort willing to provide a blood sample

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Armonea

UNKNOWN

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Wildiers

Role: STUDY_CHAIR

UZ Leuven, Belgium

Locations

Armonea nursing homes network

Mechelen, , Belgium

Countries

Belgium

Other Identifiers

EORTC-1221

Identifier Type: -

Identifier Source: org_study_id