Clinical trial NCT03560817: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Keywords: QALY
Cost-utility analysis
Time-trade-off method
Discrete choice experiment method
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Health utilities for SF-6Dv2 before chemotherapy
timeFrame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
measure: Health utilities for SF-6Dv2 after the start of the chemotherapy
timeFrame: 8 days after the start of the chemotherapy
Secondary outcomes:
measure: Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) before chemotherapy
timeFrame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
measure: Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before chemotherapy before chemotherapy
timeFrame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
measure: Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires before chemotherapy
timeFrame: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
measure: Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) after chemotherapy
timeFrame: 8 days after the start of the chemotherapy
measure: Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before after chemotherapy
timeFrame: 8 days after the start of the chemotherapy
measure: Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires after chemotherapy
timeFrame: 8 days after the start of the chemotherapy
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Thomas G Poder, PhD
role: PRINCIPAL_INVESTIGATOR
References: