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

Primary outcomes

1. Change in the spectrum of patient reported symptoms

   Time frame: 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.

2. Change in Patient reported symptom severity

   Time frame: 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

3. Change in the number of triggered alerts by the tool

   Time frame: 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.

4. Changes in Quality of Life according to QLQ-C30 Summary scores

   Time frame: 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).

5. Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival.

   Time frame: 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.

6. Changes in Patient compliance Questionnaire

   Time frame: 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).

7. Changes in patient compliance according to answering rate to symptom questionnaires

   Time frame: At 4, 8, and 12weeks

   Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests

8. Change in patient compliance according to answering rates to QLQ-C30 questionnaire

   Time frame: 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).

9. Correlation of change in baseline Hb values compared to control Hb values to treatment side-effects, cancer progression, other medical events or survival.

   Time frame: 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.

10. Correlation of change in baseline leucocyte values compared to control leucocyte values to treatment side-effects, cancer progression, other medical events or survival.

    Time frame: 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.

11. Correlation of change in baseline lymphocyte values compared to control lymphocyte values to treatment side-effects, cancer progression, other medical events or survival.

    Time frame: 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.

12. Correlation of change in baseline neutrophil values compared to control neutrophil values to treatment side-effects, cancer progression, other medical events or survival.

    Time frame: 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.

13. Correlation of change in baseline CRP values compared to control CRP values to treatment side-effects, cancer progression, other medical events or survival.

    Time frame: 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.