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Early warning system-based mental health management versus standard of care in nasopharyngeal carcinoma: a multicenter, randomized controlled trial

Early warning system-based mental health management versus standard of care in nasopharyngeal carcinoma: a multicenter, randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061084
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

nasopharyngeal carcinoma

Interventions

Intervention Group:Psychological intervention based on early warning system

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. No gender restriction, aged 18-70 years; 2. ECOG physical status score: 0-1 points; 3. Pathologically confirmed WHO type II and III nasopharyngeal carcinoma (according to the World Health Organization, WHO pathological score); 4. Stage III-IVa (according to the 8th edition of AJCC staging criteria), newly treated patients with nasopharyngeal carcinoma; 5. The treatment plan is induction chemotherapy followed by concurrent chemoradiotherapy: conventional fractionated IMRT ( PGTV: 22.20 Gy/Fx30-33F, 5F/W, total dose: >= 66.00 Gy/6.5W); the chemotherapy regimen is based on the platinum-based chemotherapy regimen selected by the investigator; 6. No serious heart disease, lung, liver, kidney and other important organ dysfunction; normal liver and kidney function: AST and ALT = 60 ml/min; adequate bone marrow function : peripheral blood leukocytes > 4.0x10^9/L, neutrophils > 2.0x10^9/L, hemoglobin > 90 g/L, platelets > 100x10^9/L; 7. The expected survival period is not less than 12 months; 8. The electronic questionnaire can be filled out independently; 9. The patients must be informed of the basic content of this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who have previously suffered from other malignant tumors (except stage I non-melanoma skin cancer or carcinoma in situ of the cervix); 2. Those who have suffered from mental diseases in the past and have not been cured; 3. Those who received tumor-related treatment before enrollment; 4. Pregnant or breastfeeding women, women of childbearing age who are not contraceptive; 5. Accompanied by other serious comorbidities, which may bring greater risks or affect the compliance of the test. For example, unstable heart disease requiring treatment, severe cerebrovascular disease, ulcer disease, kidney disease, uncontrolled diabetes mellitus (fasting blood glucose > 1.5xULN), and mental illness, etc.; 6. Those without regular follow-up conditions; 7. Do not agree to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Frequency of anxiety/depression;

Secondary

MeasureTime frame
Changes in anxiety/depression scores;Quality of Life;Efficacy evaluation;Incidence of acute toxicity;

Countries

China

Contacts

Public ContactXing Lyu

Sun Yat-sen University Cancer Center

lvxing@sysucc.org.cn+86 15920182400

Outcome results

None listed

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