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Research on the Change Trajectory of Core Symptoms and Mixed Self-Management Program in Nasopharyngeal Carcinoma Patients During the Peri-Chemoradiotherapy Period from the Perspective of Patient Journey

Research on the Construction of a PRO-Based Core Symptom Assessment System and Management Program for Head and Neck Cancer Patients Undergoing Chemoradiotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116251
Enrollment
Unknown
Registered
2026-01-07
Start date
2024-06-26
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal carcinoma(NPC)

Interventions

Control group (Intervention Component):Control group patients received routine care. During chemoradiotherapy, one-on-one education was provided on basic knowledge of chemoradiotherapy, precautions be
Trial group (Intervention Component):Receive a symptom dynamic management protocol based on best available evidence-based practices, in addition to routine care.
Observation Group (Longitudinal Study Component):None

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Longitudinal Survey Component: 1. Age >=18 years; 2. Pathologically diagnosed with nasopharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, or oropharyngeal cancer; 3. Able to understand the study content; 4. Receiving combined radiotherapy and chemotherapy; voluntarily participating in the study and signing the informed consent form. Intervention Study Component: 1. Age >=18 years; 2. Pathologically diagnosed with head and neck cancer (including nasopharyngeal, hypopharyngeal, laryngeal, and oropharyngeal cancers) and receiving concurrent chemoradiotherapy; 3. Able to understand the study content; 4. Voluntarily participating in the study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: Intervention Study Component: 1. Patients with severe primary diseases of the liver, kidney, hematopoietic, or endocrine systems accompanied by severe organ failure; 2. Patients with other malignant tumors requiring treatment; 3. Patients with severe diseases involving other vital organs; 4. Patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Patient Symptom and Function Assessment: MDASI-HN Head and Neck Specific Module, EQ-5D-5L Health Status Scale;Symptom Maximum Burden: Patients in the head and neck cancer cohort undergo multiple symptom assessments with the scale at different time points.;Worst Physiological Status: The average score of the three MDASI functional items—"general activity," "walking," and "working"—represents the patient’s physiological status; the highest score recorded during the observation period in the cohort represents the worst physiological status.;Tumor Disease and Treatment Characteristics (chemoradiotherapy regimen, complications and their grading, timing and reasons for unplanned readmissions);Targeted/Immunotherapy: Regimen, complications and their grading, timing and reasons for unplanned readmissions;MD Anderson Symptom Inventory Head and Neck Module (Intervention Component);CSCRT-HN scale;Quality of Life Questionnaire;Unplanned Hospitalizations/Emergency Department Visits;

Secondary

MeasureTime frame
Demographic Characteristics (age, gender, ethnicity, education level, residence, employment status, social support, household income);Disease and Treatment-Related Information (diagnosis, pathological type, clinical stage, history of surgery, tracheostomy, number of hospitalizations, chemotherapy cycles, radiotherapy sessions, use of targeted and immunotherapy drugs);Symptom Severity Classification Criteria: Threshold Parameters for Mild/Moderate/Severe Levels of Core Symptoms in the Head and Neck Cancer Chemoradiotherapy Symptom Scale (Draft);

Countries

China

Contacts

Public ContactLv Jianxia

Sichuan Cancer Hospital

626710213@qq.com+86 187 8290 5128

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026