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A Single-Arm, Exploratory Clinical Trial to Reduce Depression Levels in High-Risk Nasopharyngeal Cancer Patients Based on the WHO-Developed Self-help Plus (SH+) Intervention Model

A Single-Arm, Exploratory Clinical Trial to Reduce Depression Levels in High-Risk Nasopharyngeal Cancer Patients Based on the WHO-Developed Self-help Plus (SH+) Intervention Model

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087210
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Nasopharyngeal cancer:

Interventions

Experimental group:Subjects will receive a 1-month, combined offline and online self-help+ (SH+) intervention.

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years; 2. pathologically confirmed diagnosis of nasopharyngeal carcinoma; 3. proposed radiotherapy, with or without other treatments (e.g. concurrent chemotherapy, immunization, surgery, etc.); 4. score =5 and <20 on the PHQ-9 scale at baseline; 5. no prior antitumor therapy; 6. an ECOG score of 0-1; 7. able to read and understand the content of the questionnaire; 8. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with recurrent/metastatic nasopharyngeal cancer; 2. Previous history of malignant tumor; 3. those who have been previously diagnosed with clinically diagnosed psychological disorders such as depression, anxiety, etc., or are receiving treatment for mental illness, or are participating in other psychological counseling/intervention programs; 4. the presence of cognitive dysfunction, or poor comprehension; 5. with other serious illnesses that may affect adherence and follow-up.

Design outcomes

Primary

MeasureTime frame
Depressive Symptom;

Secondary

MeasureTime frame
Anxiety Symptom;Sleep Quality;Fear of Disease Progression;Illness Perception;Social Support;Quality of Life;Stress;Psychologcial distress;Psychological flexibility;Post-traumatic growth;Psychologcial distress;

Countries

China

Contacts

Public ContactJi-Bin Li

Sun Yat-sen University Cancer Center

lijib@sysucc.org.cn+86 20 8734 3360

Outcome results

None listed

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