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Clinical Trials/NCT03560817
NCT03560817
Completed
Not Applicable

Survey of Health Preferences in Cancer Patients: a Study Protocol for a Prospective, Longitudinal Cohort Using Online Survey

Centre de recherche du Centre hospitalier universitaire de Sherbrooke1 site in 1 country198 target enrollmentJanuary 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Enrollment
198
Locations
1
Primary Endpoint
Health utilities for SF-6Dv2 before chemotherapy
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2017
End Date
June 28, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Responsible Party
Principal Investigator
Principal Investigator

Thomas G. Poder

Principal Investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) before chemotherapy(Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days))
  • Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires after chemotherapy(8 days after the start of the chemotherapy)
  • Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires before chemotherapy(Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days))
  • Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before chemotherapy before chemotherapy(Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days))
  • Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) after chemotherapy(8 days after the start of the chemotherapy)
  • Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before after chemotherapy(8 days after the start of the chemotherapy)

Study Sites (1)

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