Clinical trial · Interventional
Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
- 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)
Electronic patient reported outcome (ePRO) tools have improved survival and quality of life (QoL) of cancer patients receiving chemotherapy, and in the follow-up of lung cancer patients. Current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving immune checkpoint inhibitor therapy. Current study aims to evaluate 1) patient reported symptoms and their severity, 2) Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events or survival, 3) Correlation between different symptoms and the correlation of symptoms to treatment side-effects, cancer progression, other medical events or survival,4) QoL of patients and correlation of changes in QoL to treatment side-effects, cancer progression, other medical events or survival, 5) Patient compliance, 6) Correlation of baseline laboratory values to treatment side-effects, cancer progression, other medical events or survival.
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 |
|---|---|---|---|
| Electronic patient reported outcomes | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electronic follow-up
- description
- Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool
- interventionNames
- Device: Electronic patient reported outcomes
Primary outcomes (13)
- measure
- Change in the spectrum of patient reported symptoms
- timeFrame
- At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
- description
- Percentages of patient reported symptoms using KaikuHealth 17 symptom e-questionnaire. Individual questions evaluate the presence of a specific symptom e.g. nausea. Questions are answered yes or no.
- measure
- Change in Patient reported symptom severity
- timeFrame
- At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent 2. Advanced cancers 3. Immune checkpoint inhibitor therapy initiated within +/- 2wks 4. Age \>18y 5. ECOG 0-3 6. Patient compliant with the study procedures Exclusion Criteria: 1. Immune checkpoint inhibitor therapy initiated \> 2wks ago 2. General vulnerability affecting the participation in the trial 3. No internet access
References
Publications (2)
- DERIVEDIivanainen S, Ekstrom J, Virtanen H, Kataja VV, Koivunen JP. Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies. BMC Med Inform Decis Mak. 2021 Jun 30;21(1):205. doi: 10.1186/s12911-021-01564-0. PMID 34193140
- DERIVEDIivanainen S, Alanko T, Vihinen P, Konkola T, Ekstrom J, Virtanen H, Koivunen J. Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study. JMIR Form Res. 2020 Oct 28;4(10):e17898. doi: 10.2196/17898. PMID 33112242