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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038283
• Other study ID #: HKCTR-973
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: May 13, 2016
• Start date: October 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: June 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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. — View Citation

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;6 — View Citation

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 — View Citation

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. Ep — View Citation

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/ — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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.20 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	Twelve months	No
Secondary	Health Service Utilizations	Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.	Baseline	No
Secondary	Factors Associated with HRQOL	Factors including type of treatments that may affect HRQOL of patients with CRC were explored.	Baseline	No