Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572293
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma A Phase III Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of nasopharyngeal carcinomas NPCs is highly unbalanced around the globe primarily concentrated in East and Southeast AsiaThere 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
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 Hospitals 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None