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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Mean change score from baseline in Quality of Life Assessment Tool (EORTC-QLQ-C30) [Срок оценки: 36 months after registration]

Критерии участия

Критерии включения

• Age > 18
• Histologically confirmed diagnosis of cancer
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• The ability to own and use a smartphone

Критерии исключения

• Terminal cancer
• Cognitive impairment
• Not using your smartphone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

South Korea · 1 центр

• Yongin Severance Hospital — Yongin-si

Публикации

• Holch P, Absolom KL, Henry AM, Walker K, Gibson A, Hudson E, Rogers Z, Holmes M, Peacock R, Pini S, Gilbert A, Davidson S, Routledge J, Murphy A, Franks K, Hulme C, Hewison J, Morris C, McParland L, Brown J, Velikova G. Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):664-676. doi: 10.1016/ PMID 36241128
• Bae WK, Kwon J, Lee HW, Lee SC, Song EK, Shim H, Ryu KH, Song J, Seo S, Yang Y, Park JH, Lee KH, Han HS. Feasibility and accessibility of electronic patient-reported outcome measures using a smartphone during routine chemotherapy: a pilot study. Support Care Cancer. 2018 Nov;26(11):3721-3728. doi: 10.1007/s00520-018-4232-z. Epub 2018 May 7. PMID 29732483
• Steinbeck V, Langenberger B, Schoner L, Wittich L, Klauser W, Mayer M, Kuklinski D, Vogel J, Geissler A, Pross C, Busse R. Electronic Patient-Reported Outcome Monitoring to Improve Quality of Life After Joint Replacement: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331301. doi: 10.1001/jamanetworkopen.2023.31301. PMID 37656459

Идентификаторы

NCT: NCT06598293 · 9-2024-0095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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