Clinical trial NCT04081558: Electronic Symptom Follow-up of Cancer Patients
Official title: Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
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
measure: Change in Patient reported symptom severity
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Change in the number of triggered alerts by the tool
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Changes in Quality of Life according to QLQ-C30 Summary scores
timeFrame: At baseline, and at 4, 8, and 12weeks
measure: Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival
timeFrame: At 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Changes in Patient compliance Questionnaire
timeFrame: At 4, 8, and 12weeks
measure: Changes in patient compliance according to answering rate to symptom questionnaires
timeFrame: At 4, 8, and 12weeks
measure: Change in patient compliance according to answering rates to QLQ-C30 questionnaire
timeFrame: At 4, 8, and 12weeks
Secondary outcomes:
Other outcomes:
measure: Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle in the CRC cohort
timeFrame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial
measure: Number of phone calls related to prescribing a new chemotherapy cycle in the CRC cohort
timeFrame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial
measure: Unscheduled doctor appointments in oncology unit in the CRC cohort
timeFrame: During the treatment phase of the trial or up tp 24 weeks
measure: Emergency Clinic visits in the CRC cohort
timeFrame: During the treatment phase of the trial or up to 24 weeks
measure: Days in hospitalization in the CRC cohort
timeFrame: During the treatment phase of the trial or up to 24 weeks
measure: Unscheduled investigations in health care in the CRC cohort
timeFrame: During the treatment phase of the trial or up to 24 weeks
measure: Development of peripheral neurotoxicity in the CRC cohort
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12 weeks
measure: The number of chemotherapy dose reductions
timeFrame: During the treatment phase of the trial or up to 24 weeks
measure: The number of chemotherapy delays
timeFrame: During the treatment phase of the trial or up to 24 weeks
measure: Health care user experience survey
timeFrame: Monthly during the treatment phase of the trial or up to 24 weeks
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
References: