NCT05371808

Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 247 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
OTHER	EQ-5D-5L Instrument	This instrument is a measure of health status for use in evaluating health and healthcare.
OTHER	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)
OTHER	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.

Timeline

• Start date: 2023-01-27
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2022-05-12
• Last updated: 2026-03-11

Locations

8 sites across 1 country: Canada