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

NCT05248425 | Withdrawn

• 1 other identifier: 20-6057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

ICMs; Immune Checkpoint Modulators

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  Baseline; Up to 45 months

• Overall survival at 1 year and 2 years

  1 year; 2 years

• Evaluate quality adjusted survival

  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

Study Arms (2)

Usual Care

NO INTERVENTION

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

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

Interventions

Nurse Monitoring OTHER

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.

Monitored

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participation in a therapeutic clinical trial testing anticancer therapies
• Receiving adjuvant immunotherapy

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Dacima Software Inc.: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Aaron Hansen, M.D.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 21, 2022
• Study Start: January 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CA (1)