Clinical trial · Interventional
Electronic Symptom Follow-up of Cancer Patients
Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic patient reported outcomes tool | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electronic follow-up
- interventionNames
- Device: Electronic patient reported outcomes tool
Primary outcomes (8)
- measure
- Change in the spectrum of patient reported symptoms
- timeFrame
- At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
- description
- 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.
- measure
- Change in Patient reported symptom severity
- timeFrame
- At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
- description
- Percentages of patient reported symptoms and their severity according NCI-CTCAE by KaikuHealth algorithm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIivanainen 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. PMID 40163847