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Nurse Monitoring for Cancer Patient Quality of Life (ME-Q Trial)

N/A

Waitlist Available

Led By Aaron Hansen, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Diagnosed with advanced, incurable solid tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year; 2 years

Awards & highlights

ME-Q Trial Summary

This trial is testing a tool to measure how well a patient is doing while receiving treatment for cancer with immunotherapy drugs. The goal is to see if using this tool can help improve patients' quality of life.

Who is the study for?

This trial is for English-speaking adults over 18 with advanced, incurable solid tumors who are eligible for immunotherapy. They must be able to use digital devices or web apps, have a life expectancy of at least 6 months, and provide informed consent. Those in other anticancer therapy trials or receiving adjuvant immunotherapy can't participate.Check my eligibility

What is being tested?

The ME-Q study tests whether health-related quality of life (HRQOL) can be improved by monitoring and managing symptoms in cancer patients undergoing immune checkpoint modulator (ICM) therapy using the FACT-ICM tool.See study design

What are the potential side effects?

Since this trial focuses on monitoring HRQOL rather than testing new drugs, side effects are not a primary concern here. However, typical ICM therapies may cause fatigue, skin reactions, digestive issues, and flu-like symptoms.

ME-Q Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with an advanced, incurable solid tumor.

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I am eligible for immunotherapy.

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I can care for myself but may not be able to do heavy physical work.

ME-Q Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year; 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year; 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year; 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Adherence rate and completion rate of FACT-ICM

Evaluate quality adjusted survival

Overall survival at 1 year and 2 years

+3 more

ME-Q Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MonitoredExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,519 Total Patients Enrolled

Dacima Software Inc.UNKNOWN

Aaron Hansen, M.D.Principal InvestigatorUniversity Health Network, Toronto

1 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

Nurse Monitoring Clinical Trial Eligibility Overview. Trial Name: NCT05248425 — N/A

Cancer Research Study Groups: Usual Care, Monitored

Cancer Clinical Trial 2023: Nurse Monitoring Highlights & Side Effects. Trial Name: NCT05248425 — N/A

Nurse Monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248425 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted into this study at present?

"This particular trial, as per the latest information available on clinicaltrials.gov, is not looking for more participants at this time. This study was originally posted on January 1st 2023 and was last updated November 1st 2022. There are 501 other trials that patients can consider enrolling in presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05248425.