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

Not Applicable

Not yet recruiting

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Intervention	Nurse-led intervention	Nurse-led follow-up

Primary Outcome Measures

Name	Time	Method
Quality of life score (EORTC QLQ C30)	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.
Quality of life score QLQ-HN35	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35, the range is 0-100, higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Changes in fear of recurrence	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Concerns About Recurrence Questionnaire (CARQ-4),the range is 0-40, and a higher score represents higher fear of recurrence.
Changes in Depression	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	The Patient Health Questionnaire (PHQ-9),the range is 0-27, higher scores mean a worse outcome.
Changes in knowledge, skill, and confidence for self-management	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Patient Activation Measure (PAM), interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
Changes in anxiety	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Generalized Anxiety Disorder (GAD-7),the range is 7-28, higher scores mean a worse outcome.
Changes in self-management	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	The Health Education Impact Questionnaire (heiQ), the range is 40-160, higher scores mean a better outcome.
Changes in work ability	at inclusion, 6 months,12 months, 24 months, 36 months and 60 months	Work Ability Index (WAI), range 7-49, a higher score indicated better work ability