Skip to main content
OpenTrials
Completed

NCT Number: NCT03560817

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Other

Registry information

Official study title

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

Acronym: QALY-Cancer

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2018
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.