Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients

Not Applicable

Withdrawn

Brief Summary: The ME-Q study aims to validate a patient reported outcome tool called FACT-ICM, which measures health related quality of life (HRQOL) in patients receiving immune checkpoint modulator (ICM) therapy. In addition, this trial seeks to answer if HRQOL can be improved by monitoring and managing patient symptoms whilst they are treated with ICMs.

Detailed Description: Immunotherapy has revolutionized cancer care by extending survival, but with a unique set of toxicities known as immune-related adverse events (irAEs), less is known about impact of ICMs on HRQOL.

The ME-Q trial will produce two major innovations: 1) the first validated tool to measure HRQOL in patients on ICMs that can be used in clinical trials and routine clinical care; and 2) a system to monitor and manage patient symptoms on ICMs which can enhance health care delivery for these cancer patients.

ME-Q will randomize patients who are treated with standard of care ICMs to either a monitoring arm developed specifically for this trial or the usual care arm, which is currently how they are managed. All participants will respond to HRQOL questionnaires of which FACT-ICM is a core component. A study nurse will review and manage responses which indicate new or worsening symptoms for those in the monitoring arm. The nurse will contact the patient via telephone or video teleconferencing to conduct a clinical assessment and develop a management plan following irAEs management guidelines. We hypothesize that patients on the monitoring arm will have better HRQOL, longer overall survival, fewer presentations to the emergency department and less hospital admissions than the usual care arm.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Monitored	Nurse Monitoring	All participants will answer questionnaires at specified time points. The monitored arm will have their responses reviewed for new or worsening symptoms which will be assessed and managed by a study nurse in addition to usual care.

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality Of Life measured via Functional Assessment of Cancer Therapy - General (FACT-G) at 4 months from baseline, lower scores meaning worse outcome	Baseline; 4 months

Secondary Outcome Measures

Name	Time	Method
Validity testing of FACT-ICM using Pearson or Spearman correlations between toxicity subscale and FACT-G components of the FACT-ICM and FACT-G scores	Baseline; Up to 45 months	Test-retest reliability, discriminative capacity, construct validity, responsiveness and minimally clinically important differences of FACT-ICM subscale
Overall survival at 1 year and 2 years	1 year; 2 years
Time to first Emergency Department visit and time to first hospitalization	Up to 45 months
Time on ICM therapy and time to subsequent therapy	Up to 45 months
Evaluate quality adjusted survival	Baseline; Up to 45 months	Average FACT-G scores will be multiplied by survival times for each reporting interval, with values summed to yield a total number of quality adjusted life months
Adherence rate and completion rate of FACT-ICM	Up to 45 months	Ratio of completed ePRO/ratio of ePRO reports that should have been completed within 72 hours of email alert

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