Cancer in Nursing Home Residents
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.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Mechelen、ベルギー
- Armonea nursing homes network
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Control cohort
Nursing home residents without cancer
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Cancer patient cohort
Patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken
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Biomarker cohort
Subgroup of individuals in the control cohort willing to provide a blood sample
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Prognostic capacity of p16INK4a expression in T lymphocytes on Overall Survival
時間枠:The analyses will be performed when 90 deaths will have been observed
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The analyses will be performed when 90 deaths will have been observed
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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.
時間枠:Baseline, every 3 months and for max. 2 years
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Baseline, every 3 months and for max. 2 years
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二次結果の測定
結果測定 |
時間枠 |
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Comparison of baseline parameters and outcome between nursing home cancer patients (cancer patient cohort) and nursing home non-cancer patients (control cohort)
時間枠:Baseline, every 3 months and for max. 2 years
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Baseline, every 3 months and for max. 2 years
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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).
時間枠:Baseline, every 3 months and for max. 2 years
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Baseline, every 3 months and for max. 2 years
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Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.
時間枠:2 years
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2 years
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協力者と研究者
協力者
捜査官
- スタディチェア:Hans Wildiers、UZ Leuven, Belgium
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EORTC-1221
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