Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma

Официальное название

Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma: A Phase III Randomized, Controlled Trial

Обзор

The incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among NPC patients following primary treatment compared to physician-led scheduled follow-up. Additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study. A nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.

Подробное описание

It is planned to recruit 250 primary NPC patients from Fujian Cancer Hospital's Oncology Departments during an 18-month period, after completing the chemoradiotherapy for NPC. You will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. Regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program.

Both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. The primary and secondary outcomes are measured using questionnaires in both groups, whereas Patient Reported Outcomes (PRO) are collected only in the intervention group. Relapsed patients will not be asked to complete the remaining outcome questionnaires or PROs since they quit the follow-up program to pursue recurrent treatment. If PROs reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.

Вмешательства

• Поведенческое Nurse-led intervention
  Nurse-led intervention involves patient education, collecting Patient Reported Outcomes (PRO) and evaluating them by specialists nurses, as well as navigating patients to services that can assist with their symptoms. During three-five planned appointments, the nurse will talk with you about adjusting to life after complete the radiotherapy of nasopharyngeal carcinoma, including symptoms of relapse and how to deal with them.In the first year, PROs will be collected every six months on recurrences

Первичные конечные точки

• Quality of life score (EORTC QLQ C30) [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Quality of life score QLQ-HN35 [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]

Вторичные конечные точки (6)

• Changes in knowledge, skill, and confidence for self-management [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Changes in anxiety [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Changes in self-management [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Changes in fear of recurrence [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Changes in Depression [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]
• Changes in work ability [Срок оценки: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months]

Критерии участия

Критерии включения

• Able to provide informed consent;
• Have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis;
• Aged 18 years and above;
• Expected survival ≥6 months;
• Read, understand Chinese characters and speak Mandarin.

Критерии исключения

• Previous history of other malignancies, mental illness or cognitive impairment (MMSE score < 27 points);
• Unstable medical or psychiatric conditions
• Inability to communicate effectively in mandarin
• Pregnant women or lactating women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06572293 · 2024-6-6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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