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

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

Overview

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.

Interventions

• 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)
• 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.

Primary outcome measures

• To determine incremental cost-utility ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL (enrolled in the randomized component of the SWOG S1925/CLC3 study). [Time frame: 10 years]

Secondary outcome measures (5)

• To determine incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL . Effectiveness will be expressed in life years gained [Time frame: 10 years]
• To determine the incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL. Effectiveness will be expressed in years prior to second progression gained. [Time frame: 10 years]
• To determine the direct medical costs associated with the care of Canadian high-risk CLL patients randomized to an early treatment approach compared to a deferred approach. [Time frame: 10 years]
• To compare the change in health preference (utility) over time for individuals with high-risk CLL randomized to an early approach vs. deferred treatment approach [Time frame: 10 years]
• To compare the lost productivity for Canadian individuals with high-risk CLL randomized to an early treatment approach compared to a deferred approach [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

• Patient must be eligible for the core CLC3/S1925 protocol.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 6 centers

• BCCA - Vancouver — Vancouver
• CancerCare Manitoba — Winnipeg
• Regional Health Authority B, Zone 2 — Saint John
• Lakeridge Health Oshawa — Oshawa
• Ottawa Hospital Research Institute — Ottawa
• The Jewish General Hospital — Montreal

Identifiers

NCT: NCT05371808 · CLC3E

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗