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Electronic Symptom Follow-up of Cancer Patients

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ClinicalTrials.gov Identifier: NCT04081558
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jussi Koivunen, Oulu University Hospital

Brief Summary:

Use of ePROs in oncological care have resulted in improvement of QoL, decreased ER visits, and improvement of overall survival. Furthermore, ePRO follow-up resulted in better QoL, improved ECOG status and more active cancer treatments at disease relapse, and improved survival among cancer survivals. The current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving chemotherapies or targeted therapies.

The aims of the current study are: 1) The number of alerts triggered by Kaiku Cancer medical treatment side-effects questionnaire and their correlation to treatment side-effects, other relevant medical events, tumor progression, and survival 2) Changes in Kaiku QLQ-C30 QoL questionnaire and their correlation to cancer treatment response, side-effects, other relevant medical event or survival 3) Patient compliance to Kaiku ePRO surveillance during treatment period according to response rates of Patient experience survey, Kaiku Cancer medical treatment side-effects questionnaire and Kaiku QLQ-C30 QoL questionnaire

In addition, in the CRC (colorectal cancer) cohort:

  1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle
  2. Number of phone calls related to prescribing a new chemotherapy cycle
  3. Unscheduled doctor appointments in oncology unit
  4. ER visits
  5. Days in hospitalization
  6. Unscheduled investigations in health care
  7. Development of peripheral neurotoxicity
  8. The number of chemotherapy dose reductions
  9. The number of chemotherapy delays
  10. Health care user experience survey

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Follow-up of Cancer Patients Receiving Chemotherapy or Targeted Therapy by Electronic Patient Reported Outcomes-tool
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: Electronic follow-up Device: Electronic patient reported outcomes tool
Electronic patient reported outcomes




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 15 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).


Other Outcome Measures:
  1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle in the CRC cohort [ Time Frame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial ]
    An integrated electronic follow-up tool combining patient reported outcomes and the results of the safety laboratory values taken before treatment

  2. Number of phone calls related to prescribing a new chemotherapy cycle in the CRC cohort [ Time Frame: At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial ]
    Number of un-scheduled phone calls to patients from health care professionals before a new chemotherapy cycle

  3. Unscheduled doctor appointments in oncology unit in the CRC cohort [ Time Frame: During the treatment phase of the trial or up tp 24 weeks ]
    The number of unscheduled doctor appointments in oncology unit due to patient-related issues

  4. Emergency Clinic visits in the CRC cohort [ Time Frame: During the treatment phase of the trial or up to 24 weeks ]
    The number of Emergency Clinic visits

  5. Days in hospitalization in the CRC cohort [ Time Frame: During the treatment phase of the trial or up to 24 weeks ]
    The number of days in hospitalization

  6. Unscheduled investigations in health care in the CRC cohort [ Time Frame: During the treatment phase of the trial or up to 24 weeks ]
    The number of unscheduled investigations in health care

  7. Development of peripheral neurotoxicity in the CRC cohort [ Time Frame: At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12 weeks ]
    The severity of peripheral neurotoxicity according to NCI-CTCAE By KaikuHealth algorithm

  8. The number of chemotherapy dose reductions [ Time Frame: During the treatment phase of the trial or up to 24 weeks ]
    The number of chemotherapy dose reductions due to patient-related issues

  9. The number of chemotherapy delays [ Time Frame: During the treatment phase of the trial or up to 24 weeks ]
    The number of chemotherapy delays due to patient-related issues

  10. Health care user experience survey [ Time Frame: Monthly during the treatment phase of the trial or up to 24 weeks ]
    A questionnaire assessing the feasibility of electronic follow-up from health care professionals point of view



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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. Written informed consent prior to any study procedure
  2. Advanced breast, lung, colorectal, or pancreatic cancer
  3. New cancer medical treatment, chemotherapy or targeted therapy initiated within -/+ 2 weeks from signed consent
  4. Age ≥18y
  5. ECOG 0-2
  6. CRC cohort: Patients with adjuvant treatment, or first or second line of treatment for metastatic disease
  7. Patient compliant with study procedures

Exclusion Criteria:

  1. Initiation of new cancer medical treatment > 2 wks from signed consent
  2. Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
  3. No internet access/email

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): NCT04081558


Contacts
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Contact: Jussi Koivunen +358853789 jussi.koivunen@ppshp.fi
Contact: Sanna Iivanainen +358853038

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Sanna Iivanainen    +358853038    sanna.iivanainen@ppshp.fi   
Principal Investigator: Jussi Koivunen         
Sub-Investigator: Sanna Iivanainen         
Vaasa Central Hospital Recruiting
Vaasa, Finland
Contact: Antti Jekunen       antti.jekunen@vshp.fi   
Principal Investigator: Antti Jekunen         
Sponsors and Collaborators
Oulu University Hospital
  Study Documents (Full-Text)

Documents provided by Jussi Koivunen, Oulu University Hospital:

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Responsible Party: Jussi Koivunen, adjuvant professor, medical oncologist, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT04081558     History of Changes
Other Study ID Numbers: OuluUH2
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 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