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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic follow-up | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic patient reported outcomes tool | Device | Electronic patient reported outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the spectrum of patient reported symptoms | 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. | At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks |
| Change in Patient reported symptom severity | Percentages of patient reported symptoms and their severity according NCI-CTCAE by KaikuHealth algorithm | At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks |
| Change in the number of triggered alerts by the tool | Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events in percentages or survival. | At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12weeks |
| Changes in Quality of Life according to QLQ-C30 Summary scores | 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). | At baseline, and at 4, 8, and 12weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle in the CRC cohort | An integrated electronic follow-up tool combining patient reported outcomes and the results of the safety laboratory values taken before treatment | At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | Finland | ||||
| Vaasa Central Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2019 | Sep 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Correlation between changes in different symptoms and their severity to treatment side-effects, cancer progression, other medical events, or survival |
Correlation between different patient reported symptoms and their severity to treatment side-effects, cancer progression or other medical events in percentages or survival |
| At 2-3, 4-5, 6-7, 8-9, and 11-12weeks |
| Changes in Patient compliance Questionnaire | 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). | At 4, 8, and 12weeks |
| Changes in patient compliance according to answering rate to symptom questionnaires | Patient compliance using response rates (within one week) to symptom questionnaires in percentages from sent requests | At 4, 8, and 12weeks |
| Change in patient compliance according to answering rates to QLQ-C30 questionnaire | 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). | At 4, 8, and 12weeks |
| Number of phone calls related to prescribing a new chemotherapy cycle in the CRC cohort | Number of un-scheduled phone calls to patients from health care professionals before a new chemotherapy cycle | At 2-3 weeks cycle upon chemotherapy dosing schema during the treatment phase of the trial |
| Unscheduled doctor appointments in oncology unit in the CRC cohort | The number of unscheduled doctor appointments in oncology unit due to patient-related issues | During the treatment phase of the trial or up tp 24 weeks |
| Emergency Clinic visits in the CRC cohort | The number of Emergency Clinic visits | During the treatment phase of the trial or up to 24 weeks |
| Days in hospitalization in the CRC cohort | The number of days in hospitalization | During the treatment phase of the trial or up to 24 weeks |
| Unscheduled investigations in health care in the CRC cohort | The number of unscheduled investigations in health care | During the treatment phase of the trial or up to 24 weeks |
| Development of peripheral neurotoxicity in the CRC cohort | The severity of peripheral neurotoxicity according to NCI-CTCAE By KaikuHealth algorithm | At Baseline, and at 2-3, 4-5, 6-7, 8-9, and 11-12 weeks |
| The number of chemotherapy dose reductions | The number of chemotherapy dose reductions due to patient-related issues | During the treatment phase of the trial or up to 24 weeks |
| The number of chemotherapy delays | The number of chemotherapy delays due to patient-related issues | During the treatment phase of the trial or up to 24 weeks |
| Health care user experience survey | A questionnaire assessing the feasibility of electronic follow-up from health care professionals point of view | Monthly during the treatment phase of the trial or up to 24 weeks |
| Vaasa |
| Finland |