Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma
NCT Number: NCT06572293
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nasopharyngeal Carcinoma
Interventions: BEHAVIORAL: Nurse-led intervention
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2030-12

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.

Primary Outcome Measures: 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 Outcome Measures: Changes in knowledge, skill, and confidence for self-management, 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, 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, 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, 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, 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, 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