RecruitingNCT05371808

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

Sponsor

Canadian Cancer Trials Group

Enrollment

247 participants

Start Date

Jan 27, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing the economic costs and quality of life differences between starting treatment immediately versus waiting to treat in patients newly diagnosed with asymptomatic (no symptoms yet) high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is linked to a larger clinical trial (CLC3/S1925). **You may be eligible if...** - You are eligible for and enrolled in the main CLC3/S1925 clinical trial - You are able to complete quality-of-life questionnaires in English or French - You are accessible for treatment and follow-up visits **You may NOT be eligible if...** - You are not enrolled in the core CLC3/S1925 protocol - You are able to complete the questionnaires but choose not to - You are not accessible for follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREQ-5D-5L Instrument

This instrument is a measure of health status for use in evaluating health and healthcare.

OTHERWork 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)

OTHERResource 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.