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

Not Applicable

• Conditions: Cancer
• Interventions: Device: Electronic patient reported outcomes

• Registration Number: NCT03928938
• Lead Sponsor: Oulu University Hospital

Brief Summary

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.

Detailed Description

Please see the Brief summary

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic follow-up	Electronic patient reported outcomes	Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool

Primary Outcome Measures

Name	Time	Method
Change in the spectrum of patient reported symptoms	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks	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.
Change in Patient reported symptom severity	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks	Percentages of patient reported symptoms and their severity according NCI-CTCAE by KaikuHealth algorithm
Changes in patient compliance according to answering rate to symptom questionnaires	At 4, 8, and 12weeks	Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests
Correlation of change in baseline Hb values compared to control Hb values 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 Hb values compared to control Hb values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline lymphocyte values compared to control lymphocyte values 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 at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation of change in baseline neutrophil values compared to control neutrophil values 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 at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Change in the number of triggered alerts by the tool	At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks	Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events in percentages or survival.
Correlation of change in baseline leucocyte values compared to control leucocyte values 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 compared to control leucocyte values at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival.	At 2-3, 4-5, 6-7, 8-9, and 11-12weeks	Correlation between different patient reported symptoms and their severity to treatment side-effects, cancer progression or other medical events in percentages or survival.
Change in patient compliance according to answering rates to QLQ-C30 questionnaire	At 4, 8, and 12weeks	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).
Correlation of change in baseline CRP values compared to control CRP values 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 at specific timepoints to treatment side-effects, cancer progression, other medical events or survival.
Changes in Quality of Life according to QLQ-C30 Summary scores	At baseline, and at 4, 8, and 12weeks	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).
Changes in Patient compliance Questionnaire	At 4, 8, and 12weeks	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).

Trial Locations

Locations (2)

Docarates Cancer Center; 🇫🇮 Helsinki, Finland

Pia Vihinen; 🇫🇮 Turku, Finland