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

October 13, 2024 updated by: Qiaojuan Guo, Fujian Cancer Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Nurse-led follow-up
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.
No Intervention: Control
Physician-led follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (EORTC QLQ C30)
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score QLQ-HN35
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in knowledge, skill, and confidence for self-management
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in anxiety
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in self-management
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in fear of recurrence
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in Depression
Time Frame: 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.
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in work ability
Time Frame: 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
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Investigators

  • Principal Investigator: Qiaojuan Guo, Dr., Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-6-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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