Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

13 maggio 2016 aggiornato da: Professor Cindy L.K. Lam, The University of Hong Kong

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

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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

587

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Hong Kong Island, 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SF-6D Preference-based Value
Lasso di tempo: 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).
Twelve months
Quality-adjusted life years for each screening strategy
Lasso di tempo: 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.
Baseline
Direct Health Care Costs for each CRC screening strategy
Lasso di tempo: 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.
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HRQOL by SF-12v2 and FACT-C
Lasso di tempo: Twelve months
HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.
Twelve months
Health Service Utilizations
Lasso di tempo: Baseline
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Baseline
Factors Associated with HRQOL
Lasso di tempo: Baseline
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2009

Completamento primario (Effettivo)

1 luglio 2010

Completamento dello studio (Effettivo)

1 giugno 2012

Date di iscrizione allo studio

Primo inviato

28 agosto 2013

Primo inviato che soddisfa i criteri di controllo qualità

14 gennaio 2014

Primo Inserito (Stima)

16 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

3
Sottoscrivi