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

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ClinicalTrials.gov Identifier: NCT03928938
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jussi Koivunen, 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.


Condition or disease Intervention/treatment Phase
Cancer Device: Electronic patient reported outcomes Not Applicable

Detailed Description:
Please see the Brief summary

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : September 30, 2019

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928938


Contacts
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Contact: Jussi P Koivunen, M.D., Ph.D +35883153789 jussi.koivunen@ppshp.fi
Contact: Sanna Iivanainen, M.D. +35883153038 sanna.iivanainen@ppshp.fi

Locations
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Finland
Docarates Cancer Center Recruiting
Helsinki, Finland, 00180
Contact: Tuomo Alanko, M.D., Ph.D         
Principal Investigator: Tuomo Alanko, M.D., Ph.D         
Pia Vihinen Recruiting
Turku, Finland, 20521
Contact: Pia Vihinen, MD, Ph.D         
Principal Investigator: Pia Vihinen, MD, Ph.D         
Sponsors and Collaborators
Oulu University Hospital
Investigators
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Principal Investigator: Jussi P Koivunen, M.D., Ph.D Oulu University Hospital
  Study Documents (Full-Text)

Documents provided by Jussi Koivunen, Oulu University Hospital:

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Responsible Party: Jussi Koivunen, principal investigator, associate professor, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT03928938     History of Changes
Other Study ID Numbers: 9/2017
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No