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

University Health Network, Toronto

Status: Withdrawn

Conditions: Cancer

Treatments: Other: Nurse Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05248425

20-6057

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Usual Care

No Intervention group

Description:

All participants will answer questionnaires at specified time points. This arm will receive usual care and their questionnaire responses will not be reviewed.

Monitored

Experimental group

Description:

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.

Treatment:

Other: Nurse Monitoring