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Trial record 50 of 318 for:    colon cancer | ( Map: Canada )

Survey of Health Preferences in Cancer Patients (QALY-Cancer) (QALY-Cancer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560817
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas G. Poder, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information
First Submitted Date April 27, 2018
First Posted Date June 18, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date January 4, 2017
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2018)
  • Health utilities for SF-6Dv2 before chemotherapy [ Time Frame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days) ]
    Health utilities measured by SF-6Dv2 health states using a hybrid method combining time-trade-off (TTO) and discrete choice experiment (DCE)
  • Health utilities for SF-6Dv2 after the start of the chemotherapy [ Time Frame: 8 days after the start of the chemotherapy ]
    Health utilities measured by SF-6Dv2 health states using a hybrid method combining time-trade-off (TTO) and discrete choice experiment (DCE)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03560817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 15, 2018)
  • Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) before chemotherapy [ Time Frame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days) ]
    The EQ-5D-5L included five health dimensions with five response levels of 1 to 5. A score is calculated using an already pre-established regression equation using time-trade-off method. The health utilities range from -0.148 for the worst EQ-5D-5L state to 0.949 for the best EQ-5D-5L state.
  • Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before chemotherapy before chemotherapy [ Time Frame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days) ]
    The EORTC QLQ-C30 questionnaire were developed by the European Organisation for Research and Treatment of Cancer (EORTC). Including 30items, evaluating five functions, nine symptoms, and the overall health status of patients with cancer. Scales will be calculated by averaging the items. Items and scales will be linearly transformed to a range of 0 to 100. A higher score indicate a better quality of life or higher symptoms.
  • Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires before chemotherapy [ Time Frame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days) ]
    The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. It include 27 questions, each of which is answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Higher numbers indicate a better health state. The score will be calculated with the sum of items and score will be normalised on a scale from 0-100.
  • Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) after chemotherapy [ Time Frame: 8 days after the start of the chemotherapy ]
    The EQ-5D-5L included five health dimensions with five response levels of 1 to 5. A score is calculated using an already pre-established regression equation using time-trade-off method. The health utilities range from -0.148 for the worst EQ-5D-5L state to 0.949 for the best EQ-5D-5L state.
  • Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before after chemotherapy [ Time Frame: 8 days after the start of the chemotherapy ]
    The EORTC QLQ-C30 questionnaire were developed by the European Organisation for Research and Treatment of Cancer (EORTC). Including 30items, evaluating five functions, nine symptoms, and the overall health status of patients with cancer. Scales will be calculated by averaging the items. Items and scales will be linearly transformed to a range of 0 to 100. A higher score indicate a better quality of life or higher symptoms.
  • Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires after chemotherapy [ Time Frame: 8 days after the start of the chemotherapy ]
    The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. It include 27 questions, each of which is answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Higher numbers indicate a better health state. The score will be calculated with the sum of items and score will be normalised on a scale from 0-100.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survey of Health Preferences in Cancer Patients (QALY-Cancer)
Official Title Survey of Health Preferences in Cancer Patients: a Study Protocol for a Prospective, Longitudinal Cohort Using Online Survey
Brief Summary This study will evaluate health utilities in patients with breast or colorectal cancer.
Detailed Description

The cost-utility analysis (CUA) is an increasingly used method to help health decision-maker. The CUA uses the Quality Adjusted Life Years (QALY) that combines the length of life with the health related quality of life (HRQoL) into a single score.

In Quebec, no QALY calculation tool has been adapted to its linguistic and socio-cultural context, neither for its general population nor for a particular subpopulation, like patients with cancer.

The objectives will be to analyze the extent of the divergence in terms of health states utilities between the general population and patients with breast or colorectal cancer; to develop a QALY preference weights dataset for patients with cancer; to perform "mapping" with different health-related quality of life questionnaires by correlating SF6Dv2 with EQ-5D-5L, EORTC QLQ-C30 and FACT- G. The data will be collected with a self-administered online survey. Patients outcomes will be measured at the beginning of the chemotherapy treatment cycle and about 8 days after the start of chemotherapy. Health utilities will be measured with a hybrid method using the time-trade-off (TTO) and the discrete experimental choice (DCE) method using SF6Dv2 questionnaire for health states.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target population consists of the Quebec population aged 18 and over who have breast cancer or colorectal cancer.
Condition
  • Breast Cancer
  • Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts
  • breast cancer
    No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.
  • colorectal cancer
    No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 5, 2019)
198
Original Estimated Enrollment
 (submitted: June 15, 2018)
210
Actual Study Completion Date June 28, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • to be 18 years of age or older;
  • to reside in Quebec;
  • have already had a chemotherapy treatment cycle;
  • be on the eve of a new round of chemotherapy treatment;
  • have breast or colorectal cancer

Exclusion Criteria:

  • being over 80 years of age;
  • not be able to complete a computer questionnaire;
  • can not read or write in French;
  • not be able to sign a consent form;
  • the only treatment offered is surgery;
  • presence of metastases to the brain;
  • patient with delirium, psychosis or severe depression (i.e. chronic condition with treatment)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03560817
Other Study ID Numbers 2017-1490
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Thomas G. Poder, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Sponsor Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators Not Provided
Investigators
Principal Investigator: Thomas G Poder, PhD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
PRS Account Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Verification Date August 2019