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

Breast Cancer Clinical Trial

— QALY-Cancer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560817
• Other study ID #: 2017-1490
• Status: Completed
• Start date: January 4, 2017
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Canada	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health utilities for SF-6Dv2 before chemotherapy	Health utilities measured by SF-6Dv2 health states using a hybrid method combining time-trade-off (TTO) and discrete choice experiment (DCE)	Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
Primary	Health utilities for SF-6Dv2 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)	8 days after the start of the chemotherapy
Secondary	Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) before 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.	Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
Secondary	Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before chemotherapy before 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.	Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
Secondary	Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires before 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.	Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
Secondary	Health utilities with the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) after 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.	8 days after the start of the chemotherapy
Secondary	Health related quality of life (HRQoL) scores from EORTC QLQ-C30 questionnaire before after 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.	8 days after the start of the chemotherapy
Secondary	Health related quality of life (HRQoL) scores from the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires after 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.	8 days after the start of the chemotherapy