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CancerNCT04081558

Electronic Symptom Follow-up of Cancer Patients

A study testing Electronic patient reported outcomes tool 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
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Trial summary

Use of ePROs in oncological care have resulted in improvement of QoL, decreased ER visits, and improvement of overall survival. Furthermore, ePRO follow-up resulted in better QoL, improved ECOG status and more active cancer treatments at disease relapse, and improved survival among cancer survivals. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Electronic patient reported outcomes tool
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 Jan 2018to 31 May 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

  • Written informed consent prior to any study procedure
  • Advanced breast, lung, colorectal, or pancreatic cancer
  • New cancer medical treatment, chemotherapy or targeted therapy initiated within -/+ 2 weeks from signed consent
  • Age ≥18y
  • ECOG 0-2
  • CRC cohort: Patients with adjuvant treatment, or first or second line of treatment for metastatic disease
  • Patient compliant with study procedures

Who cannot join

  • Initiation of new cancer medical treatment > 2 wks from signed consent
  • Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
  • No internet access/email

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Oulu University Hospital

    Oulu

  • Vaasa Central Hospital

    Vaasa

Other trials in Finland

About this study

Official title: Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool

Use of ePROs in oncological care have resulted in improvement of QoL, decreased ER visits, and improvement of overall survival. Furthermore, ePRO follow-up resulted in better QoL, improved ECOG status and more active cancer treatments at disease relapse, and improved survival among cancer survivals. The current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving chemotherapies or targeted therapies.

The aims of the current study are: 1) The number of alerts triggered by Kaiku Cancer medical treatment side-effects questionnaire and their correlation to treatment side-effects, other relevant medical events, tumor progression, and survival 2) Changes in Kaiku QLQ-C30 QoL questionnaire and their correlation to cancer treatment response, side-effects, other relevant medical event or survival 3) Patient compliance to Kaiku ePRO surveillance during treatment period according to response rates of Patient experience survey, Kaiku Cancer medical treatment side-effects questionnaire and Kaiku QLQ-C30 QoL questionnaire

Read more

In addition, in the CRC (colorectal cancer) cohort:

  1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle
  2. Number of phone calls related to prescribing a new chemotherapy cycle
  3. Unscheduled doctor appointments in oncology unit
  4. ER visits
  5. Days in hospitalization
  6. Unscheduled investigations in health care
  7. Development of peripheral neurotoxicity
  8. The number of chemotherapy dose reductions
  9. The number of chemotherapy delays
  10. Health care user experience survey
Conditions
Cancer
Being tested
Electronic patient reported outcomes tool
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 outcomes toolDevice

    Electronic patient reported outcomes

Study groups in NCT04081558
Study groupRoleWhat they receive
Electronic follow-upExperimentalNot described
Receives: Device: Electronic patient reported outcomes tool

What is being measured

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

  1. Change in the spectrum of patient reported symptoms

    Percentages of patient reported symptoms using KaikuHealth 15 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Timeline

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

  1. First posted9 Sep 2019
  2. Study start1 Jan 2018
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

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
NCT04081558
Sponsor's protocol ID
OuluUH2
Status last verified
Aug 2025
First submitted
4 Sep 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, Arokoski R, Mentu S, Lang L, Ekstrom J, Virtanen H, Kataja V, Koivunen JP. Development of a Comprehensive Decision Support Tool for Chemotherapy-Cycle Prescribing: Initial Usability Study. JMIR Form Res. 2025 Mar 31;9:e62749. doi: 10.2196/62749.

    PubMed 40163847

Questions about this trial

What is this clinical trial studying?

A study testing Electronic patient reported outcomes tool 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 7 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 8 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 NCT04081558, which also lists 1 linked publication.

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.

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