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Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:
Sponsor: Canadian Cancer Trials Group
Summary
Utilization data will be collected from all patients entered on the trial at Canadian centres from the time of registration until death, removal from study, or completion of 10 years of follow-up. Protocol-specified health care utilization will be collected within trial case report forms, and will include study visits, radiographic assessments, laboratory investigations, and treatment administration. Resource utilization data collection will be supplemented by a self-administered resource utilization form (Stanford SMRC) to document non-protocol specified utilization. This will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.
Official title: An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3/SWOG 1925 Randomized Phase III Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
247
Start Date
2023-01-27
Completion Date
2028-10-01
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
EQ-5D-5L Instrument
This instrument is a measure of health status for use in evaluating health and healthcare.
Work Productivity and Daily Activity Impairment (WPAI) survey
The questionnaire includes three open-ended questions that determines: 1) hours absent from work due to health problems; 2) hours absent from work due to other reasons; and (3) hours actually worked over the past 30 days. Additional questions ask about the impact of health problems on work productivity and daily activities and are scored along a vertical visual analog scale. The WPAI provides estimates on absenteeism, presenteeism, global measures of lost productivity (absenteeism+presenteeism) and daily activity impairment (impaired ability to perform non-work activities including work around the house, child care, exercise, studying, and leisure activities)
Resource Utilization Form (SMRC)
Resource utilization data collection will be supplemented by a self-administered resource utilization form (Stanford SMRC) to document non-protocol specified utilization. This will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.
Locations (8)
BCCA - Vancouver
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
The Jewish General Hospital
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada