An observational study in Colorectal Neoplasms, sponsored by The University of Hong Kong. Completed at 3 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-16.
Sponsored by The University of Hong Kong · Observational
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.
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:
The study hypotheses are:
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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.
Exclusion Criteria:
≤2 adenomas or 3-4 adenomas all of which are \<1cm
≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm
at least six months since diagnosis of Stage I CRC
at least six months since diagnosis of Stage II CRC
at least six months since diagnosis of Stage III CRC
at least six months since diagnosis of Stage IV CRC
SF-6D Preference-based Value
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).
Time frame: Twelve months
Quality-adjusted life years for each screening strategy
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.
Time frame: Baseline
Direct Health Care Costs for each CRC screening strategy
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.
Time frame: Baseline
HRQOL by SF-12v2 and FACT-C
HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.
Time frame: Twelve months
Health Service Utilizations
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Time frame: Baseline
Factors Associated with HRQOL
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Time frame: Baseline
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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