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NCT Number: NCT04081558

Electronic Symptom Follow-up of Cancer Patients

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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital, Oulu, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Electronic patient reported outcomes tool

Device

Electronic patient reported outcomes

Primary outcomes

  1. 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 15 symptom e-questionnaire. Individual questions evaluate the presence of a specific symptom e.g. nausea. Questions are answered yes or no.

  2. 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

  3. 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.

  4. 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).

  5. 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

  6. 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).

  7. 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

  8. 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).

Other outcomes

  1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle in the CRC cohort

    Time frame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial

    An integrated electronic follow-up tool combining patient reported outcomes and the results of the safety laboratory values taken before treatment

  2. Number of phone calls related to prescribing a new chemotherapy cycle in the CRC cohort

    Time frame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial

    Number of un-scheduled phone calls to patients from health care professionals before a new chemotherapy cycle

  3. Unscheduled doctor appointments in oncology unit in the CRC cohort

    Time frame: During the treatment phase of the trial or up tp 24 weeks

    The number of unscheduled doctor appointments in oncology unit due to patient-related issues

  4. Emergency Clinic visits in the CRC cohort

    Time frame: During the treatment phase of the trial or up to 24 weeks

    The number of Emergency Clinic visits

  5. Days in hospitalization in the CRC cohort

    Time frame: During the treatment phase of the trial or up to 24 weeks

    The number of days in hospitalization

  6. Unscheduled investigations in health care in the CRC cohort

    Time frame: During the treatment phase of the trial or up to 24 weeks

    The number of unscheduled investigations in health care

  7. Development of peripheral neurotoxicity in the CRC cohort

    Time frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12 weeks

    The severity of peripheral neurotoxicity according to NCI-CTCAE By KaikuHealth algorithm

  8. The number of chemotherapy dose reductions

    Time frame: During the treatment phase of the trial or up to 24 weeks

    The number of chemotherapy dose reductions due to patient-related issues

  9. The number of chemotherapy delays

    Time frame: During the treatment phase of the trial or up to 24 weeks

    The number of chemotherapy delays due to patient-related issues

  10. Health care user experience survey

    Time frame: Monthly during the treatment phase of the trial or up to 24 weeks

    A questionnaire assessing the feasibility of electronic follow-up from health care professionals point of view

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2019
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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