Electronic Symptom Follow-up of Cancer Patients

NCT ID: NCT04081558

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-05-31

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

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electronic follow-up

Group Type: EXPERIMENTAL

Electronic patient reported outcomes tool

Intervention Type: DEVICE

Electronic patient reported outcomes

Interventions

Electronic patient reported outcomes tool

Electronic patient reported outcomes

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jussi Koivunen

adjuvant professor, medical oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oulu University Hospital

Oulu, , Finland

Vaasa Central Hospital

Vaasa, , Finland

Countries

Finland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OuluUH2

Identifier Type: -

Identifier Source: org_study_id