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Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening

2016年5月13日 更新者:Professor Cindy L.K. Lam、The University of Hong Kong

A Study on Health-related Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening in Hong Kong

Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong Kong and the second leading cause of cancer death in this population. Several screening strategies has been associated with improved survival and may affect patients' health-related quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any intervention including screening.

Objectives: to determine the HRQOL and health preference of patients with different stages of colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for increasing QALYs.

Design and Subjects: A longitudinal survey to collect data on HRQOL associated with colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified sample of 420 patients with colorectal polyps and different stages of CRC will be recruited from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment. The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference data will be integrated with cost and effectiveness data obtained from the literature to determine the cost-effectiveness of currently recommended CRC screening strategies by Markov modeling.

Main outcome measures: The primary outcome measure is the SF-6D health preference value and QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared between patients with different stages of colorectal neoplasm. Markov modeling study will estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC screening strategy.

Results: The study will provide information on HRQOL of patients with colorectal neoplasm to guide health services. The Markov Model will identify the most cost-effective CRC screening strategy for Hong Kong Chinese, which can inform policy makers and the public for the prevention of CRC of the population.

調査の概要

状態

完了

詳細な説明

The aims are to determine the HRQOL and health preference (utility) of different stages of colorectal neoplasm in order to evaluate the cost-effectiveness of different CRC screening strategies for the Chinese population in Hong Kong.

The specific objectives are:

  1. To determine the HRQOL preference values of patients in different stage of colorectal neoplasm in order to estimate the quality of life adjustment applicable to each stage of colorectal neoplasm.
  2. To evaluate the HRQOL of patients with colorectal neoplasm in order to find out their concerns and needs.
  3. To find out whether HRQOL preference of people with colorectal neoplasm changes with time.
  4. To determine the expected life years gained from the reduction in the incidence and mortality rates of CRC for each CRC screening strategy base on literature review.
  5. To determine the QALY gained from each CRC strategy by combining the preference value with life years gained.
  6. To identify the most cost-effective CRC screening strategy and to determine the incremental cost per additional QALY gained compared to no screening, by Markov modelling.

The study hypotheses are:

  1. Patients with colorectal neoplasm including those with polyps have lower HRQOL than the general population.
  2. There is a gradient reduction in HRQOL preference among patients with different stages colorectal neoplasm from polyp to metastatic cancer.
  3. HRQOL preference of patients with colorectal neoplasm is stable if there is no change in the disease stage.
  4. Annual I-FOBT is the most cost-effective CRC screening strategy for the Chinese population in Hong Kong.

研究の種類

観察的

入学 (実際)

587

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

      • Hong Kong Island、香港
        • Department of Clinical Oncology, Faculty of Medicine, The University of Hong Kong
      • Hong Kong Island、香港
        • Department of Medicine, Queen Mary Hospital
      • Hong Kong Island、香港
        • Department of Surgery, Faculty of Medicine, The University of Hong Kong

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

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

All Chinese patients of 18 years old or above with a histology of confirmed colorectal polyp or cancer for at least six months were recruited from specialist outpatient medical and surgical colorectal clinics of Queen Mary hospital in Hong Kong.

説明

Inclusion Criteria:

  • Age 18 years or above
  • Have life expectancy of at least 6 months
  • Have confirmed diagnosis of any of the following colorectal neoplasm classified by the screening surveillance guideline and UICC/AJCC (TNM) staging system
  • Have given consent to take part in the study

Exclusion Criteria:

  • Inability to understand or communicate in Cantonese or Chinese
  • Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
  • Too ill to carry out an interview
  • Refuse to give consent

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
Low-risk Colorectal Polyps
≤2 adenomas or 3-4 adenomas all of which are <1cm
High-risk Colorectal Polyps
≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm
Stage I CRC
at least six months since diagnosis of Stage I CRC
Stage II CRC
at least six months since diagnosis of Stage II CRC
Stage III CRC
at least six months since diagnosis of Stage III CRC
Stage IV CRC
at least six months since diagnosis of Stage IV CRC

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
メジャーの説明
時間枠
SF-6D Preference-based Value
時間枠:Twelve months
HRQOL preference value measured by The Chinese (HK) SF-6D Health Survey was calculated by the HK population specific algorithm. It ranges from 0 (death) to 1 (perfect health).
Twelve months
Quality-adjusted life years for each screening strategy
時間枠:Baseline
The effectiveness of CRC screening is quantified by Quality-adjusted life years, which was calculated as the product of average duration of each health state (including no illness) and the SF-6D preference value for that particular health state.
Baseline
Direct Health Care Costs for each CRC screening strategy
時間枠:Baseline
The direct health care costs of different CRC screening strategies and treatments of different stages of CRC were estimated using the costs published by the Government Gazette.
Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
HRQOL by SF-12v2 and FACT-C
時間枠:Twelve months
HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.
Twelve months
Health Service Utilizations
時間枠:Baseline
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Baseline
Factors Associated with HRQOL
時間枠:Baseline
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Baseline

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。

スポンサー

捜査官

  • 主任研究者:Cindy L.K. Lam, MD、Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2009年10月1日

一次修了 (実際)

2010年7月1日

研究の完了 (実際)

2012年6月1日

試験登録日

最初に提出

2013年8月28日

QC基準を満たした最初の提出物

2014年1月14日

最初の投稿 (見積もり)

2014年1月16日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年5月16日

QC基準を満たした最後の更新が送信されました

2016年5月13日

最終確認日

2016年5月1日

詳しくは

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