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

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ClinicalTrials.gov Identifier: NCT02038283
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : May 16, 2016
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Professor Cindy L.K. Lam, The University of Hong Kong

Brief Summary:

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.


Condition or disease
Colorectal Neoplasms

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 587 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038283


Locations
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Hong Kong
Department of Clinical Oncology, Faculty of Medicine, The University of Hong Kong
Hong Kong Island, Hong Kong
Department of Medicine, Queen Mary Hospital
Hong Kong Island, Hong Kong
Department of Surgery, Faculty of Medicine, The University of Hong Kong
Hong Kong Island, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Food and Health Bureau, Hong Kong
Investigators
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Principal Investigator: Cindy L.K. Lam, MD Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Cindy L.K. Lam, Head and Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02038283     History of Changes
Other Study ID Numbers: HKCTR-973
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Professor Cindy L.K. Lam, The University of Hong Kong:
Colorectal Neoplasms
Early Detection of Cancer
Quality of Life
Quality-Adjusted Life Years
Direct Service Costs
Cost-Benefit Analysis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases