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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients Receiving Immune Checkpoint Modulators

Conditions
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Cancer

Intervention / Treatment
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* Other: Nurse Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Diagnosed with advanced, incurable solid tumors Eligible for immunotherapy (monotherapy or combination ICM) Life expectancy ≥ 6 months ECOG PS 0-3 Fluent in English Able to provide informed consent Able to complete questionnaires using digital device or web based application Exclusion Criteria: Participation in a therapeutic clinical trial testing anticancer therapies Receiving adjuvant immunotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>All participants will answer questionnaires at specified time points. This arm will receive usual care and their questionnaire responses will not be reviewed. | |
| Experimental: Monitored<br>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. | Other: Nurse Monitoring<br>* Questionnaire responses that indicate new or worsening symptoms will be monitored by a study nurse who will contact the participant for clinical assessment and develop a management plan following irAEs management guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Test-retest reliability, discriminative capacity, construct validity, responsiveness and minimally clinically important differences of FACT-ICM subscale | Baseline; Up to 45 months | 
| Overall survival at 1 year and 2 years |  | 1 year; 2 years | 
| Evaluate quality adjusted survival | 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 | Baseline; Up to 45 months | 
| 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 | 
| Adherence rate and completion rate of FACT-ICM | Ratio of completed ePRO/ratio of ePRO reports that should have been completed within 72 hours of email alert | Up to 45 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICMs, Immune Checkpoint Modulators