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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

Brief Summary:
This study will evaluate health utilities in patients with breast or colorectal cancer.

Condition or disease
Breast Cancer 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.


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Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey of Health Preferences in Cancer Patients: a Study Protocol for a Prospective, Longitudinal Cohort Using Online Survey
Actual Study Start Date : January 4, 2017
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560817


Locations
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Canada, Quebec
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Investigators
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Principal Investigator: Thomas G Poder, PhD Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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Responsible Party: Thomas G. Poder, Principal Investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT03560817     History of Changes
Other Study ID Numbers: 2017-1490
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas G. Poder, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
QALY
Cost-utility analysis
Time-trade-off method
Discrete choice experiment method

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases