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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

完了

研究の種類

観察的

入学 (実際)

125

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Mechelen、ベルギー
        • Armonea nursing homes network

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
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

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
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
The analyses will be performed when 90 deaths will have been observed
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
Baseline, every 3 months and for max. 2 years

二次結果の測定

結果測定
時間枠
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
Baseline, every 3 months and for max. 2 years
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
Baseline, every 3 months and for max. 2 years
Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.
時間枠:2 years
2 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

協力者

捜査官

  • スタディチェア:Hans Wildiers、UZ Leuven, Belgium

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年10月1日

一次修了 (実際)

2017年12月1日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2013年7月24日

QC基準を満たした最初の提出物

2013年7月25日

最初の投稿 (見積もり)

2013年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2019年3月13日

QC基準を満たした最後の更新が送信されました

2019年3月12日

最終確認日

2019年3月1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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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