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Trial Title:
Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma
NCT ID:
NCT06572293
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Nasopharyngeal Carcinoma
Nurse-Led Individualized Follow-Up
post-radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nurse-led intervention
Description:
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.
Arm group label:
Intervention
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
November 2024
Completion date:
December 2030
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572293
