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

Cancer Clinical Trial

— ME-Q  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05248425
• Other study ID #: 20-6057
• Status: Withdrawn
• Phase: N/A
• Start date: January 2023
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Dacima Software Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall survival at 1 year and 2 years		1 year; 2 years
Secondary	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
Secondary	Time to first Emergency Department visit and time to first hospitalization		Up to 45 months
Secondary	Time on ICM therapy and time to subsequent therapy		Up to 45 months
Secondary	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