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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Please see the Brief summary

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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

Group Type EXPERIMENTAL

Electronic patient reported outcomes

Intervention Type DEVICE

Electronic patient reported outcomes-tool

Interventions

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Electronic patient reported outcomes

Electronic patient reported outcomes-tool

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jussi Koivunen

principal investigator, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Pia Vihinen

Turku, , Finland

Site Status

Countries

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Finland

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.

Reference Type DERIVED
PMID: 34193140 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33112242 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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9/2017

Identifier Type: -

Identifier Source: org_study_id

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