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Usability of Patient-Reported Outcomes-Based Electronic System in Managing Anxiety and Depression in Nasopharyngeal Carcinoma: a Prospective, Single-Arm Trial

Usability of Patient-Reported Outcomes-Based Electronic System in Managing Anxiety and Depression in Nasopharyngeal Carcinoma: a Prospective, Single-Arm Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065965
Enrollment
Unknown
Registered
2022-11-21
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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 systems

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 or those under treatment; 5. The treatment plan is induction chemotherapy followed by concurrent chemoradiotherapy: conventional fractionated IMRT (PGTV: 22.20 Gy/F x 30-33 F, 5 F/W, total dose: >= 66.00 Gy/6.5 W); 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, ALT = 60 mL/min; adequate bone marrow function : Peripheral blood leukocytes > 4.0 x 10^9/L, neutrophils > 2.0 x 10^9/L, hemoglobin > 90 g/L, platelets > 100 x 10^9/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. Pregnant or breastfeeding women, women of childbearing age who are not contraceptive; 4. 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 > 1.5 x ULN), and mental illness, etc.; 5. Those without regular follow-up conditions; 6. Patients with self-harm/suicidal tendencies; 7. Patients who may discontinue treatment due to anxiety/depression; 8. Do not agree to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Frequency of anxiety/depression;

Secondary

MeasureTime frame
Telemedicine Usability Evaluation;Brief INSPIRE Questionnaire;Changes in anxiety/depression scores;Quality of Life;Insomnia severity;Cancer related fatigue;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