Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
NCT ID: NCT03928938
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2017-06-01
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Electronic follow-up
Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool
Electronic patient reported outcomes
Electronic patient reported outcomes-tool
Interventions
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Electronic patient reported outcomes
Electronic patient reported outcomes-tool
Eligibility Criteria
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Inclusion Criteria
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
2. General vulnerability affecting the participation in the trial
3. No internet access
18 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Responsible Party
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Jussi Koivunen
principal investigator, associate professor
Principal Investigators
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Jussi P Koivunen, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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Docarates Cancer Center
Helsinki, , Finland
Pia Vihinen
Turku, , Finland
Countries
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References
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Iivanainen 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.
Iivanainen 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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9/2017
Identifier Type: -
Identifier Source: org_study_id
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