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

NCT02038283 | Completed

• 1 other identifier: HKCTR-973
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Neoplasms

Keywords

Colorectal Neoplasms; Early Detection of Cancer; Quality of Life; Quality-Adjusted Life Years; Direct Service Costs; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Baseline

Secondary Outcomes (3)

• HRQOL by SF-12v2 and FACT-C

  Twelve months

• Health Service Utilizations

  Baseline

• Factors Associated with HRQOL

  Baseline

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (3)

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

Hong Kong Island, Hong Kong

Location

Department of Medicine, Queen Mary Hospital

Hong Kong Island, Hong Kong

Location

Department of Surgery, Faculty of Medicine, The University of Hong Kong

Hong Kong Island, Hong Kong

Location

Related Publications (13)

• Wong CK, Lam CL, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Validity and reliability study on traditional Chinese FACT-C in Chinese patients with colorectal neoplasm. J Eval Clin Pract. 2012 Dec;18(6):1186-95. doi: 10.1111/j.1365-2753.2011.01753.x. Epub 2011 Aug 18.

  PMID: 21851512 RESULT

• Wong CK, Lam CL, Poon JT, McGhee SM, Law WL, Kwong DL, Tsang J, Chan P. Direct medical costs of care for Chinese patients with colorectal neoplasia: a health care service provider perspective. J Eval Clin Pract. 2012 Dec;18(6):1203-10. doi: 10.1111/j.1365-2753.2011.01776.x. Epub 2011 Nov 23.

  PMID: 22111837 RESULT

• Wong CK, Lam CL, Rowen D, McGhee SM, Ma KP, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Mapping the Functional Assessment of Cancer Therapy-general or -Colorectal to SF-6D in Chinese patients with colorectal neoplasm. Value Health. 2012 May;15(3):495-503. doi: 10.1016/j.jval.2011.12.009. Epub 2012 Feb 17.

  PMID: 22583460 RESULT

• Wong CK, Lam CL, Mulhern B, Law WL, Poon JT, Kwong DL, Tsang J. Measurement invariance of the Functional Assessment of Cancer Therapy-Colorectal quality-of-life instrument among modes of administration. Qual Life Res. 2013 Aug;22(6):1415-26. doi: 10.1007/s11136-012-0272-x. Epub 2012 Sep 28.

  PMID: 23054490 RESULT

• Wong CK, Lam CL, Poon JT, Kwong DL. Clinical correlates of health preference and generic health-related quality of life in patients with colorectal neoplasms. PLoS One. 2013;8(3):e58341. doi: 10.1371/journal.pone.0058341. Epub 2013 Mar 13.

  PMID: 23516465 RESULT

• Wong CK, Lam CL, Law WL, Poon JT, Kwong DL, Tsang J, Wan YF. Condition-specific measure was more responsive than generic measure in colorectal cancer: all but social domains. J Clin Epidemiol. 2013 May;66(5):557-65. doi: 10.1016/j.jclinepi.2012.11.010. Epub 2013 Feb 8.

  PMID: 23548135 RESULT

• Wong CK, Lam CL, Wan YF, Rowen D. Predicting SF-6D from the European Organization for Treatment and Research of Cancer Quality of Life Questionnaire scores in patients with colorectal cancer. Value Health. 2013 Mar-Apr;16(2):373-84. doi: 10.1016/j.jval.2012.12.004.

  PMID: 23538190 RESULT

• Wong CK, Mulhern B, Wan YF, Lam CL. Responsiveness was similar between direct and mapped SF-6D in colorectal cancer patients who declined. J Clin Epidemiol. 2014 Feb;67(2):219-27. doi: 10.1016/j.jclinepi.2013.08.011. Epub 2013 Nov 1.

  PMID: 24189090 RESULT

• Wong CK, Law WL, Wan YF, Poon JT, Lam CL. Health-related quality of life and risk of colorectal cancer recurrence and All-cause death among advanced stages of colorectal cancer 1-year after diagnosis. BMC Cancer. 2014 May 17;14:337. doi: 10.1186/1471-2407-14-337.

  PMID: 24886385 RESULT

• Yang Y, Wong MY, Lam CL, Wong CK. Improving the mapping of condition-specific health-related quality of life onto SF-6D score. Qual Life Res. 2014 Oct;23(8):2343-53. doi: 10.1007/s11136-014-0668-x. Epub 2014 Mar 29.

  PMID: 24682669 RESULT

• Wong CK, Chen J, Yu CL, Sham M, Lam CL. Systematic review recommends the European Organization for Research and Treatment of Cancer colorectal cancer-specific module for measuring quality of life in colorectal cancer patients. J Clin Epidemiol. 2015 Mar;68(3):266-78. doi: 10.1016/j.jclinepi.2014.09.021. Epub 2014 Nov 6.

  PMID: 25455838 RESULT

• Lam CL, Law WL, Poon JT, Chan P, Wong CK, McGhee SM, Fong DY. Health-related quality of life in patients with colorectal neoplasm and cost-effectiveness of colorectal cancer screening in Hong Kong. Hong Kong Med J. 2015 Dec;21 Suppl 6:4-8. No abstract available.

  PMID: 26645874 RESULT

• Wong CK, Lam CL, Wan YF, Fong DY. Cost-effectiveness simulation and analysis of colorectal cancer screening in Hong Kong Chinese population: comparison amongst colonoscopy, guaiac and immunologic fecal occult blood testing. BMC Cancer. 2015 Oct 15;15:705. doi: 10.1186/s12885-015-1730-y.

  PMID: 26471036 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cindy L.K. Lam, MD

  Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and Clinical Professor

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: January 16, 2014
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2012
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

HK (3)