Electronic Symptom Follow-up of Cancer Patients

Cancer Clinical Trial

Official title:

Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081558
• Other study ID #: OuluUH2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2021
• Source: Oulu University Hospital
• Contact: Jussi Koivunen
• Phone: +358853789
• Email: jussi.koivunen[@]ppshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Electronic patient reported outcomes tool
Electronic patient reported outcomes

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu
Finland	Vaasa Central Hospital	Vaasa

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle in the CRC cohort	An integrated electronic follow-up tool combining patient reported outcomes and the results of the safety laboratory values taken before treatment	At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial
Other	Number of phone calls related to prescribing a new chemotherapy cycle in the CRC cohort	Number of un-scheduled phone calls to patients from health care professionals before a new chemotherapy cycle	At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial
Other	Unscheduled doctor appointments in oncology unit in the CRC cohort	The number of unscheduled doctor appointments in oncology unit due to patient-related issues	During the treatment phase of the trial or up tp 24 weeks
Other	Emergency Clinic visits in the CRC cohort	The number of Emergency Clinic visits	During the treatment phase of the trial or up to 24 weeks
Other	Days in hospitalization in the CRC cohort	The number of days in hospitalization	During the treatment phase of the trial or up to 24 weeks
Other	Unscheduled investigations in health care in the CRC cohort	The number of unscheduled investigations in health care	During the treatment phase of the trial or up to 24 weeks
Other	Development of peripheral neurotoxicity in the CRC cohort	The severity of peripheral neurotoxicity according to NCI-CTCAE By KaikuHealth algorithm	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12 weeks
Other	The number of chemotherapy dose reductions	The number of chemotherapy dose reductions due to patient-related issues	During the treatment phase of the trial or up to 24 weeks
Other	The number of chemotherapy delays	The number of chemotherapy delays due to patient-related issues	During the treatment phase of the trial or up to 24 weeks
Other	Health care user experience survey	A questionnaire assessing the feasibility of electronic follow-up from health care professionals point of view	Monthly during the treatment phase of the trial or up to 24 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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