Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening
NCT ID: NCT02038283
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
587 participants
OBSERVATIONAL
2009-10-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong
NCT03597204
The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong
NCT04815525
Screening for Colorectal Neoplasm in First Degree Relatives of the Affected
NCT00164944
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
NCT00280332
Effectiveness of Using Mobile Health Technology in Colorectal Cancer Screening Uptake
NCT06192862
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-risk Colorectal Polyps
≤2 adenomas or 3-4 adenomas all of which are \<1cm
No interventions assigned to this group
High-risk Colorectal Polyps
≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm
No interventions assigned to this group
Stage I CRC
at least six months since diagnosis of Stage I CRC
No interventions assigned to this group
Stage II CRC
at least six months since diagnosis of Stage II CRC
No interventions assigned to this group
Stage III CRC
at least six months since diagnosis of Stage III CRC
No interventions assigned to this group
Stage IV CRC
at least six months since diagnosis of Stage IV CRC
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Queen Mary Hospital, Hong Kong
OTHER
Food and Health Bureau, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Cindy L.K. Lam
Head and Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cindy L.K. Lam, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HKCTR-973
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.