Electronic Symptom Follow-up of Cancer Patients

Not Applicable

• Conditions: Cancer

• Registration Number: NCT04081558
• Lead Sponsor: Oulu University Hospital

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. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Patient reported symptom severity	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 spectrum of patient reported symptoms	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.
Changes in Patient compliance Questionnaire	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).
Change in patient compliance according to answering rates to QLQ-C30 questionnaire	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).
Changes in Quality of Life according to QLQ-C30 Summary scores	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).
Change in the number of triggered alerts by the tool	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.
Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival	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 according to answering rate to symptom questionnaires	At 4, 8, and 12weeks	Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests

Trial Locations

Locations (2)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland