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NCT Number: NCT02038283

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, Faculty of Medicine, The University of Hong Kong, Hong Kong Island, Hong Kong

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About this study

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:

  • 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.
  • To evaluate the HRQOL of patients with colorectal neoplasm in order to find out their concerns and needs.
  • To find out whether HRQOL preference of people with colorectal neoplasm changes with time.
  • 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.
  • To determine the QALY gained from each CRC strategy by combining the preference value with life years gained.
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. SF-6D Preference-based Value

    Time frame: 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).

  2. Quality-adjusted life years for each screening strategy

    Time frame: 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.

  3. Direct Health Care Costs for each CRC screening strategy

    Time frame: 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.

Secondary outcomes

  1. HRQOL by SF-12v2 and FACT-C

    Time frame: Twelve months

    HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.

  2. Health Service Utilizations

    Time frame: Baseline

    Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.

  3. Factors Associated with HRQOL

    Time frame: Baseline

    Factors including type of treatments that may affect HRQOL of patients with CRC were explored.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Food and Health Bureau, Hong Kong
  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 16, 2014
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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