Clinical trial NCT03928938: Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
Official title: Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor 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: 2019-04-26
Enrollment: 40
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: 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

Eligibility criteria: 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

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
measure: Correlation of change in baseline Hb values compared to control Hb values to treatment side-effects, cancer progression, other medical events or survival.
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Correlation of change in baseline leucocyte values compared to control leucocyte values to treatment side-effects, cancer progression, other medical events or survival.
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Correlation of change in baseline lymphocyte values compared to control lymphocyte values to treatment side-effects, cancer progression, other medical events or survival.
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Correlation of change in baseline neutrophil values compared to control neutrophil values to treatment side-effects, cancer progression, other medical events or survival.
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
measure: Correlation of change in baseline CRP values compared to control CRP values to treatment side-effects, cancer progression, other medical events or survival.
timeFrame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Docarates Cancer Center
city: Turku
country: Finland
facility: Pia Vihinen
Study officials:
affiliation: Oulu University Hospital
name: Jussi P Koivunen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.