NCT06598293

Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study

Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study (REPROM)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 536 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 3\~6 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 3\~6 months after treatment. \*Study design: a prospective randomized parallel-group pilot study

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	PRO-CTCAE, Pain NRS	The Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a PROM developed to systematically and objectively reflect patients' experiences and perceptions of therapeutic drugs in toxicity evaluation and adverse event reporting. PRO-CTCAE can be used to monitor patients' symptoms and side effects, support therapeutic decision-making, facilitate communication among medical staff, implement patient-centred care, and screen for health conditions.

Timeline

• Start date: 2024-09-03
• Primary completion: 2027-07-30
• Completion: 2028-02-28
• First posted: 2024-09-19
• Last updated: 2024-09-27

Locations

1 site across 1 country: South Korea