Clinical trial NCT05248425: Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients
Official title: A Randomized Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients Receiving Immune Checkpoint Modulators
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Keywords: ICMs
Immune Checkpoint Modulators
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Dacima Software Inc.
First posted: 2022-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline; 4 months
Secondary outcomes:
measure: 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
timeFrame: Baseline; Up to 45 months
measure: Overall survival at 1 year and 2 years
timeFrame: 1 year; 2 years
measure: Evaluate quality adjusted survival
timeFrame: Baseline; Up to 45 months
measure: Time to first Emergency Department visit and time to first hospitalization
timeFrame: Up to 45 months
measure: Time on ICM therapy and time to subsequent therapy
timeFrame: Up to 45 months
measure: Adherence rate and completion rate of FACT-ICM
timeFrame: Up to 45 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Aaron Hansen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: