Breast CancerQALY-CancerNCT03560817

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

An observational study of Breast Cancer and Colorectal Cancer, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate health utilities in patients with breast or colorectal cancer. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Breast Cancer, Colorectal Cancer
How many people: 198 participants
Where: 1 siteCanada
Study dates: 4 Jan 2017to 28 Jun 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The target population consists of the Quebec population aged 18 and over who have breast cancer or colorectal cancer.

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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

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

Read the 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.

Conditions: Breast Cancer, Colorectal Cancer
Keywords: QALY, Cost-utility analysis, Time-trade-off method, Discrete choice experiment method
Medical subject headings: Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03560817
Study group	Role	What they receive
breast cancer		No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.
colorectal cancer		No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Within two days before the start of a chemotherapy treatment cycle (standard treatment; each cycle is 21 days)
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)
Measured: 8 days after the start of the chemotherapy

Secondary outcomes (6)

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.
Measured: 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
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.
Measured: 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 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.
Measured: 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
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.
Measured: 8 days after the start of the chemotherapy
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.
Measured: 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 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.
Measured: 8 days after the start of the chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 201728 Jun 2019

First posted18 Jun 2018
Study start4 Jan 2017
Primary completion28 Jun 2019
Study completion28 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03560817
Sponsor's protocol ID: 2017-1490
Acronym: QALY-Cancer
Status last verified: Aug 2019
First submitted: 27 Apr 2018
Last updated: 7 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey of Health Preferences in Cancer Patients: a Study Protocol for a Prospective, Longitudinal Cohort Using Online Survey
ClinicalTrials.gov ID: NCT03560817
Acronym / sponsor ID: QALY-Cancer / 2017-1490
Conditions: Breast Cancer, Colorectal Cancer
Keywords: QALY, Cost-utility analysis, Time-trade-off method, Discrete choice experiment method
Study type: Observational
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
Study start: 4 Jan 2017 (actual)
Primary completion: 28 Jun 2019 (actual)
Study completion: 28 Jun 2019 (actual)
First posted: 18 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
breast cancer	–	–No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.
colorectal cancer	–	–No intervention is added with the study. Patients follow their standard treatment and respond to an online questionnaire about their health preferences.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The target population consists of the Quebec population aged 18 and over who have breast cancer or colorectal cancer.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

6 secondary outcomes

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)
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)
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)
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas G Poder, PhD principal investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Colorectal Cancer, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.