Clinical trial · Observational
Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
NCT03326973CI-TRIAL-00048923completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EORTC QLQ-C30 | Behavioral | — | UNRESOLVED |
| EuroQoL EQ-5D-3L | Behavioral | — | UNRESOLVED |
| Fatigue severity score questionnaire | Behavioral | — | UNRESOLVED |
| Physician information | Behavioral | — | UNRESOLVED |
| PRO-CTCAE | Other | — | UNRESOLVED |
| The COST | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- online or telephone survey
- description
- This is a cross-sectional survey. Our main method of communication with patients will be email. Participants will complete a single online or telephone survey at a minimum of 12 months post initial treatment of checkpoint inhibitors and remain on maintenance therapy.
- interventionNames
- Behavioral: EuroQoL EQ-5D-3L
- Behavioral: EORTC QLQ-C30
- Other: PRO-CTCAE
- Behavioral: Fatigue severity score questionnaire
- Behavioral: The COST
- Behavioral: Physician information
Primary outcomes (1)
- measure
- total score of Global QOL overall health index
- timeFrame
- 1 year
- description
- On the EQ-5D-3L, respondents are asked to indicate their health state by marking the box associated with the most appropriate statement in each of the 5 dimensions, resulting in a one digit number expressing the level (1-3) selected for that dimension from no problems to extreme problems.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be able to speak and read English * Be able to provide informed consent * Have been diagnosed with metastatic melanoma at age 18 years or older * Have been treated with either single agent or combination checkpoint inhibitor * Be at least 12 months since first dose of above named agents * Received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist) Exclusion Criteria: * Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team * Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers * Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record * Patients with symptomatic progression but continue on immunotherapy * Note: For any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist
References
Publications (0)
Data not yet available
No reference posted for this study.