Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598293
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy A Randomized Controlled Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy A Randomized Controlled Study REPROM
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPROM
Brief Summary:
Patients in this study will be asked to periodically self-report their symptoms using their smartphones during the radiotherapy period and during the acute phase 3 months after treatment and radiation oncology physicians will evaluate the impact on cancer patients quality of life and determine whether they can improve health outcomes by using this data in their practice
Detailed Description:
The purpose of this study is to determine the efficacy feasibility and acceptability of routine PROM reporting using smartphones during treatment and during the acute phase after treatment in patients undergoing radiotherapy
Subjects who voluntarily consent to the study will be assigned to either the test group or the control group through randomization
Test group REPROM group Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy once a week during treatment at the end of treatment once a week until one month after treatment and at 1 month and 36 months after treatment PRO-CTCAE Pain NRS The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this
A survey alert is sent to the patient at the time of REPROM implementation and the subject uses a smartphone to conduct a self-report questionnaire on patient symptoms sent through the mobile messenger KakaoTalk as shown in the screenshot below The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation A score of 4 or higher will be automatically alerted to the attending physician and the research nurse and the research nurse may contact the subject if necessary and recommend additional care to the attending physician
Control group Usual care group Control subjects receive usual care without self-report of REPROM Subjects in both groups may receive appropriate medical attention for the symptoms observed at the time of treatment Subjects in both groups will be asked to take HR-QOL questionnaires EORTC-QLQ-C30 EQ-5D-5L EQ-VAS before radiotherapy at the end of treatment at 1 month after treatment and at 36 months after treatment
Study design a prospective randomized parallel-group pilot study
Subjects who voluntarily consent to the study will be assigned to either the test group or the control group through randomization
Test group REPROM group Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy once a week during treatment at the end of treatment once a week until one month after treatment and at 1 month and 36 months after treatment PRO-CTCAE Pain NRS The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this
A survey alert is sent to the patient at the time of REPROM implementation and the subject uses a smartphone to conduct a self-report questionnaire on patient symptoms sent through the mobile messenger KakaoTalk as shown in the screenshot below The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation A score of 4 or higher will be automatically alerted to the attending physician and the research nurse and the research nurse may contact the subject if necessary and recommend additional care to the attending physician
Control group Usual care group Control subjects receive usual care without self-report of REPROM Subjects in both groups may receive appropriate medical attention for the symptoms observed at the time of treatment Subjects in both groups will be asked to take HR-QOL questionnaires EORTC-QLQ-C30 EQ-5D-5L EQ-VAS before radiotherapy at the end of treatment at 1 month after treatment and at 36 months after treatment
Study design a prospective randomized parallel-group pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None