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

NCT06572293 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

BEHAVIORAL

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 and late effects, and thereafter every 12 months. PRO will be administered to patients for three years after the nurse appointments are finalized.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Qiaojuan Guo, Dr. · Fujian Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572293 on ClinicalTrials.gov