Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool

Electronic patient reported outcome (ePRO) tools have improved survival and quality of life (QoL) of cancer patients receiving chemotherapy, and in the follow-up of lung cancer patients. Current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving immune checkpoint inhibitor therapy.

Current study aims to evaluate 1) patient reported symptoms and their severity, 2) Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events or survival, 3) Correlation between different symptoms and the correlation of symptoms to treatment side-effects, cancer progression, other medical events or survival,4) QoL of patients and correlation of changes in QoL to treatment side-effects, cancer progression, other medical events or survival, 5) Patient compliance, 6) Correlation of baseline laboratory values to treatment side-effects, cancer progression, other medical events or survival.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Device: Electronic patient reported outcomes

Detailed Description

Please see the Brief summary

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jussi P Koivunen, M.D., Ph.D; Phone Number: +35883153789; Email: jussi.koivunen@ppshp.fi
• Study Contact Backup: Name: Sanna Iivanainen, M.D.; Phone Number: +35883153038; Email: sanna.iivanainen@ppshp.fi

Study Locations

• Finland
  • Helsinki, Finland, 00180
    • Recruiting
    • Docarates Cancer Center
    • Contact: Tuomo Alanko, M.D., Ph.D
    • Principal Investigator: Tuomo Alanko, M.D., Ph.D
  • Turku, Finland, 20521
    • Recruiting
    • Pia Vihinen
    • Contact: Pia Vihinen, MD, Ph.D
    • Principal Investigator: Pia Vihinen, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent
2. Advanced cancers
3. Immune checkpoint inhibitor therapy initiated within +/- 2wks
4. Age >18y
5. ECOG 0-3
6. Patient compliant with the study procedures

Exclusion Criteria:

1. Immune checkpoint inhibitor therapy initiated > 2wks ago
2. General vulnerability affecting the participation in the trial
3. No internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electronic follow-up; Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool	Device: Electronic patient reported outcomes; Electronic patient reported outcomes-tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the spectrum of patient reported symptoms	Percentages of patient reported symptoms using KaikuHealth 17 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
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
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
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
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
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
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
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
Correlation of change in baseline Hb values compared to control Hb values to treatment side-effects, cancer progression, other medical events or survival.	Correlation of change in baseline Hb values compared to control Hb values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline leucocyte values compared to control leucocyte values to treatment side-effects, cancer progression, other medical events or survival.	Correlation of change in baseline leucocyte compared to control leucocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline lymphocyte values compared to control lymphocyte values to treatment side-effects, cancer progression, other medical events or survival.	Correlation of change in baseline lymphocyte values compared to control lymphocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline neutrophil values compared to control neutrophil values to treatment side-effects, cancer progression, other medical events or survival.	Correlation of change in baseline neutrophil values compared to control neutrophil values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Correlation of change in baseline CRP values compared to control CRP values to treatment side-effects, cancer progression, other medical events or survival.	Correlation of change in baseline CRP values compared to control CRP values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Investigators: Principal Investigator: Jussi P Koivunen, M.D., Ph.D, Oulu University Hospital

Publications and helpful links

General Publications

• Iivanainen S, Ekstrom J, Virtanen H, Kataja VV, Koivunen JP. Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies. BMC Med Inform Decis Mak. 2021 Jun 30;21(1):205. doi: 10.1186/s12911-021-01564-0.
• Iivanainen S, Alanko T, Vihinen P, Konkola T, Ekstrom J, Virtanen H, Koivunen J. Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study. JMIR Form Res. 2020 Oct 28;4(10):e17898. doi: 10.2196/17898.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 9/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No