Clinical trial · Interventional
Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients
A Randomized Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients Receiving Immune Checkpoint Modulators
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Feasibility.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nurse Monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- All participants will answer questionnaires at specified time points. This arm will receive usual care and their questionnaire responses will not be reviewed.
- type
- EXPERIMENTAL
- label
- Monitored
- 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.
- interventionNames
- Other: Nurse Monitoring
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available