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

2016년 5월 13일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

587

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
SF-6D Preference-based Value
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
HRQOL by SF-12v2 and FACT-C
기간: 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
기간: Baseline
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Baseline
Factors Associated with HRQOL
기간: Baseline
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 10월 1일

기본 완료 (실제)

2010년 7월 1일

연구 완료 (실제)

2012년 6월 1일

연구 등록 날짜

최초 제출

2013년 8월 28일

QC 기준을 충족하는 최초 제출

2014년 1월 14일

처음 게시됨 (추정)

2014년 1월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 5월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 5월 13일

마지막으로 확인됨

2016년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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