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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05248425
Other study ID # 20-6057
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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