Electronic Symptom Follow-up of Cancer Patients

NCT04081558 | Completed

• 1 other identifier: OuluUH2
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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).

  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

  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).

  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

  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).

  At 4, 8, and 12weeks

Other Outcomes (10)

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

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

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

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

• Unscheduled doctor appointments in oncology unit in the CRC cohort

  During the treatment phase of the trial or up tp 24 weeks

Study Arms (1)

Electronic follow-up

EXPERIMENTAL

Device: Electronic patient reported outcomes tool

Interventions

Electronic patient reported outcomes tool DEVICE

Electronic patient reported outcomes

Electronic follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oulu University Hospital: lead

Study Sites (2)

Oulu University Hospital

Oulu, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjuvant professor, medical oncologist

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: January 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)