NCT03560817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

April 27, 2018

Last Update Submit

August 5, 2019

Conditions

Breast CancerColorectal Cancer

Keywords

QALYCost-utility analysisTime-trade-off methodDiscrete choice experiment method

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (6)

  • 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 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 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 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

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Thomas G Poder, PhD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2018

First Posted

June 18, 2018

Study Start

January 4, 2017

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)