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出境医 / 临床实验 / Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool
Study Description
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
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| 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, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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.
- 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
- 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.
- 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).
- 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.
- 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).
- 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
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent
- Advanced cancers
- Immune checkpoint inhibitor therapy initiated within +/- 2wks
- Age >18y
- ECOG 0-3
- Patient compliant with the study procedures
Exclusion Criteria:
- Immune checkpoint inhibitor therapy initiated > 2wks ago
- General vulnerability affecting the participation in the trial
- No internet access
Contacts and Locations
Contacts
| Contact: Jussi P Koivunen, M.D., Ph.D | +35883153789 | jussi.koivunen@ppshp.fi | |
| Contact: Sanna Iivanainen, M.D. | +35883153038 | sanna.iivanainen@ppshp.fi |
Locations
| 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
| Principal Investigator: | Jussi P Koivunen, M.D., Ph.D | Oulu University Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 29, 2019 | ||||||||
| First Posted Date ICMJE | April 26, 2019 | ||||||||
| Last Update Posted Date | February 24, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 1, 2017 | ||||||||
| Estimated Primary Completion Date | May 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool | ||||||||
| Official Title ICMJE | Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool | ||||||||
| 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. |
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| Detailed Description | Please see the Brief summary | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Cancer | ||||||||
| Intervention ICMJE | Device: Electronic patient reported outcomes
Electronic patient reported outcomes-tool
|
||||||||
| Study Arms ICMJE | Experimental: Electronic follow-up
Follow-up of cancer patients treated with immune checkpoint inhibitor therapy using electronic patient reported outcomes-tool
Intervention: Device: Electronic patient reported outcomes
|
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| Publications * | 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 30, 2021 | ||||||||
| Estimated Primary Completion Date | May 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Finland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03928938 | ||||||||
| Other Study ID Numbers ICMJE | 9/2017 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jussi Koivunen, Oulu University Hospital | ||||||||
| Study Sponsor ICMJE | Oulu University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Oulu University Hospital | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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