Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients (ME-Q)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Other: Nurse Monitoring

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C1
      • Princess Margaret Cancer Centre
      • Contact: Grace Silver; Phone Number: 2440 (416) 946-4501; Email: grace.silver@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Dacima Software Inc.
• Investigators: Principal Investigator: Aaron Hansen, M.D., University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ICMs; Immune Checkpoint Modulators
• Other Study ID Numbers: 20-6057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No