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

NCT06572293 | Not Yet Recruiting

• 1 other identifier: 2024-6-6
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Nurse-Led Individualized Follow-Up; post-radiotherapy

Outcome Measures

Primary Outcomes (2)

• Quality of life score (EORTC QLQ C30)

  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

  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 Outcomes (6)

• Changes in knowledge, skill, and confidence for self-management

  at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

• Changes in anxiety

  at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

• Changes in self-management

  at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

• Changes in fear of recurrence

  at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

• Changes in Depression

  at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Study Arms (2)

Intervention

EXPERIMENTAL

Nurse-led follow-up

Behavioral: Nurse-led intervention

Control

NO INTERVENTION

Physician-led follow-up

Interventions

Nurse-led intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Qiaojuan Guo, Dr.

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyi Wu, Dr.

CONTACT

8618150833735; wuziyi@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 27, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 16, 2024

Record last verified: 2024-10