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

Completed
Conditions
Breast Cancer
Colorectal Cancer
Registration Number
NCT03560817
Lead Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
198
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Health utilities for SF-6Dv2 before chemotherapyWithin 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 chemotherapy8 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
NameTimeMethod
Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) before chemotherapyWithin 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 the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires after chemotherapy8 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.

Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires before chemotherapyWithin 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 related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before chemotherapy before chemotherapyWithin 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 utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) after chemotherapy8 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 chemotherapy8 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.

Trial Locations

Locations (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

🇨🇦

Sherbrooke, Quebec, Canada

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