CancerNCT03928938

Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool

A study testing Electronic patient reported outcomes in people with Cancer, run by Oulu University Hospital at 2 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: Electronic patient reported outcomes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 2 sitesFinland
Study dates: 1 Jun 2017to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent
Advanced cancers
Immune checkpoint inhibitor therapy initiated within +/- 2wks
Age >18y
ECOG 0-3
Patient compliant with the study procedures

Who cannot join

Immune checkpoint inhibitor therapy initiated > 2wks ago
General vulnerability affecting the participation in the trial
No internet access

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

Docarates Cancer Center
Helsinki, 00180
Pia Vihinen
Turku, 20521

Other trials in Finland

About this study

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.

Read the detailed description

Please see the Brief summary

Conditions: Cancer
Being tested: Electronic patient reported outcomes
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electronic patient reported outcomesDevice
Electronic patient reported outcomes-tool

Study groups in NCT03928938
Study group	Role	What they receive
Electronic follow-up	Experimental	Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool Receives: Device: Electronic patient reported outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the spectrum of patient reported symptoms
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.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Change in Patient reported symptom severity
Percentages of patient reported symptoms and their severity according NCI-CTCAE by KaikuHealth algorithm
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Change in the number of triggered alerts by the tool
Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events in percentages or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Changes in Quality of Life according to QLQ-C30 Summary scores
The correlation of the Summary score of QLQ-C30 to treatment side-effects, cancer progression, or other medical events or survival.
The Core Quality of life questionnaire (QLQ-C30) is a validated cancer health-related quality-of-life questionnaire that includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality of life and financial impact. Subjects respond on a four-point-scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale. For the functioning scales and global QoL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden. The summary score of QLQ-C30 is calculated from the mean of 13 of 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
Measured: At baseline, and at 4, 8, and 12weeks
Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival.
Correlation between different patient reported symptoms and their severity to treatment side-effects, cancer progression or other medical events in percentages or survival.
Measured: At 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Changes in Patient compliance Questionnaire
Patient compliance using KaikuHealth e-questionnaire addressing usability (easiness to use from scale: very easy to very difficult; need of assistance to use the program: yes/no; how understandable are questions in symptom questionnaire from scale: totally agree to totally disagree) and user experience (use of the ePRO tool will better your cancer care: yes-no, do not know; use of the ePRO tool has been useful: yes-no-do not know; would you recommend the ePRO tool for cancer care: yes-no-do not know). Analysis is done on percentages of each answer choice at specific time point(s).
Measured: At 4, 8, and 12weeks
Changes in patient compliance according to answering rate to symptom questionnaires
Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests
Measured: At 4, 8, and 12weeks
Change in patient compliance according to answering rates to QLQ-C30 questionnaire
Patient compliance using response rates to QLQ-C30 questionnaires (within one week) in percentages from sent requests. The QLQ-C30 questionnaire includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality of life and financial impact. Subjects respond on a four-point-scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale. For the functioning scales and global QoL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden. The summary score of QLQ-C30 is calculated from the mean of 13 of 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
Measured: At 4, 8, and 12weeks
Correlation of change in baseline Hb values compared to control Hb values to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline Hb values compared to control Hb values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline leucocyte values compared to control leucocyte values to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline leucocyte compared to control leucocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline lymphocyte values compared to control lymphocyte values to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline lymphocyte values compared to control lymphocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline neutrophil values compared to control neutrophil values to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline neutrophil values compared to control neutrophil values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline CRP values compared to control CRP values to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline CRP values compared to control CRP values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Measured: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201731 Dec 2022

First posted26 Apr 2019
Study start1 Jun 2017
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03928938
Sponsor's protocol ID: 9/2017
Status last verified: Aug 2025
First submitted: 29 Jan 2019
Last updated: 29 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34193140
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.
PubMed 33112242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

All Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
ClinicalTrials.gov ID: NCT03928938
Acronym / sponsor ID: 9/2017
Conditions: Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Oulu University HospitalUniversity, hospital or other
Study start: 1 Jun 2017 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 26 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Please see the Brief summary

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Electronic follow-up	Experimental	Device: Electronic patient reported outcomesFollow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed informed consent
Advanced cancers
Immune checkpoint inhibitor therapy initiated within +/- 2wks
Age >18y
ECOG 0-3

Key exclusion criteria (3 listed)

Immune checkpoint inhibitor therapy initiated > 2wks ago
General vulnerability affecting the participation in the trial
No internet access

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electronic patient reported outcomesElectronic patient reported outcomes-tool	Device	Electronic follow-up

Primary outcome

Change in the spectrum of patient reported symptoms
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
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.
Change in Patient reported symptom severity
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Percentages of patient reported symptoms and their severity according NCI-CTCAE by KaikuHealth algorithm
Change in the number of triggered alerts by the tool
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events in percentages or survival.
Changes in Quality of Life according to QLQ-C30 Summary scores
Time frame: At baseline, and at 4, 8, and 12weeks
The correlation of the Summary score of QLQ-C30 to treatment side-effects, cancer progression, or other medical events or survival. The Core Quality of life questionnaire (QLQ-C30) is a validated cancer health-related quality-of-life questionnaire that includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality of life and financial impact. Subjects respond on a four-point-scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale. For the functioning scales and global QoL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden. The summary score of QLQ-C30 is calculated from the mean of 13 of 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival.
Time frame: At 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation between different patient reported symptoms and their severity to treatment side-effects, cancer progression or other medical events in percentages or survival.
Changes in Patient compliance Questionnaire
Time frame: At 4, 8, and 12weeks
Patient compliance using KaikuHealth e-questionnaire addressing usability (easiness to use from scale: very easy to very difficult; need of assistance to use the program: yes/no; how understandable are questions in symptom questionnaire from scale: totally agree to totally disagree) and user experience (use of the ePRO tool will better your cancer care: yes-no, do not know; use of the ePRO tool has been useful: yes-no-do not know; would you recommend the ePRO tool for cancer care: yes-no-do not know). Analysis is done on percentages of each answer choice at specific time point(s).
Changes in patient compliance according to answering rate to symptom questionnaires
Time frame: At 4, 8, and 12weeks
Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests
Change in patient compliance according to answering rates to QLQ-C30 questionnaire
Time frame: At 4, 8, and 12weeks
Patient compliance using response rates to QLQ-C30 questionnaires (within one week) in percentages from sent requests. The QLQ-C30 questionnaire includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality of life and financial impact. Subjects respond on a four-point-scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale. For the functioning scales and global QoL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden. The summary score of QLQ-C30 is calculated from the mean of 13 of 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included).
Correlation of change in baseline Hb values compared to control Hb values to treatment side-effects, cancer progression, other medical events or survival.
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline Hb values compared to control Hb values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline leucocyte values compared to control leucocyte values to treatment side-effects, cancer progression, other medical events or survival.
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline leucocyte compared to control leucocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline lymphocyte values compared to control lymphocyte values to treatment side-effects, cancer progression, other medical events or survival.
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline lymphocyte values compared to control lymphocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline neutrophil values compared to control neutrophil values to treatment side-effects, cancer progression, other medical events or survival.
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline neutrophil values compared to control neutrophil values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline CRP values compared to control CRP values to treatment side-effects, cancer progression, other medical events or survival.
Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline CRP values compared to control CRP values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Derived from this study: PubMed 34193140Iivanainen 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.
Derived from this study: PubMed 33112242Iivanainen 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.
Individual participant dataSharing planned: No

Related trials for Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jussi P Koivunen, M.D., Ph.D principal investigator

Oulu University Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electronic patient reported outcomes in people with Cancer, run by Oulu University Hospital at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the spectrum of patient reported symptoms (time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03928938, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.