Clinical trial NCT06572293: Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma
Official title: Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma: A Phase III Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Nurse-Led Individualized Follow-Up
post-radiotherapy
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of life score (EORTC QLQ C30)
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Quality of life score QLQ-HN35
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Secondary outcomes:
measure: Changes in knowledge, skill, and confidence for self-management
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in anxiety
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in self-management
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in fear of recurrence
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in Depression
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in work ability
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Cancer Hospital
name: Qiaojuan Guo, Dr.
role: PRINCIPAL_INVESTIGATOR
References: