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Clinical practice and discussion of narrative medicine in the whole process management of patients with advanced lung cancer

Clinical practice and discussion of narrative medicine in the whole process management of patients with advanced lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054097
Enrollment
Unknown
Registered
2021-12-08
Start date
2021-12-08
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Lung cancer

Interventions

single arm:Narrative medicine

Sponsors

The Fifth Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 18-75 years, male or female; 3. Those with clear consciousness, clear self-expression and no mental disorder; 4. According to the 8th edition of the TNM staging of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, locally advanced or metastatic disease confirmed by histology or cytology that cannot be treated by surgery and cannot receive radical concurrent chemoradiotherapy (III B, IIIC, NSCLC patients with stage IV); 5. At least one tumor lesion that can be measured repeatedly according to RECIST1.1 criteria; 6. Have not received anti-tumor therapy before; 7. Expected survival period >= 3 months; 8. ECOG status score is 0-1; 9. The level of organ function must meet the following requirements: Hematological indicators: absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 90 g/L; liver function: Total bilirubin = 60ml/min; coagulation function: INR, PT and APTT <= 1.5 times the upper limit of normal; ECG is basically normal; 10. Female subjects of childbearing age must undergo a serum pregnancy test and the result is negative, and they are not breast-feeding. If they have sex with a non-sterilized male partner, they must take acceptable and effective measures from the start of screening to 120 days after the last dose. Contraceptive methods; unsterilized male subjects who have sex with female partners of childbearing age must use acceptable and effective contraceptive methods from the start of screening to 120 days after the last dose.

Exclusion criteria

Exclusion criteria: 1. Previous mental illness or family history; 2. Those who use psychoactive drugs; 3. Those who do not know the condition; 4. The language expression is unclear due to multiple factors and the self-care ability assessment is less than 90 points; 5. The subject has cancerous meningitis; 6. Subjects with active central nervous system (CNS) metastases were excluded. Subjects can participate in the study if their CNS metastases can be adequately treated and their neurological symptoms can return to baseline levels at least 2 weeks prior to enrollment (except for residual signs or symptoms related to CNS treatment). In addition, the subject must also be a corticosteroid-free subject or receive a stable or tapering dose of <=10 mg/day of prednisone (or equivalent); 7. Have coagulation dysfunction or bleeding tendency, or have a history of thrombosis or bleeding disease; 8. There are unhealed wound ulcers or fractures; 9. According to chest X-ray examination, sputum examination and clinical physical examination, it is judged to have active pulmonary tuberculosis (TB) infection. Patients with a history of active pulmonary tuberculosis infection within the previous 1 year, even if they have been treated, should be excluded; patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proved that the course and type of anti-TB treatment previously used are appropriate.

Design outcomes

Primary

MeasureTime frame
Treatment decision;

Secondary

MeasureTime frame
Treatment implementation;Anxiety and depression score;Short term efficacy and toxicity;Quality of life score;sleep quality;Hematological indexes;

Countries

China

Contacts

Public ContactYang Xiaoyue

The Fifth affiliated Hospital of Sun Yat-Sen University

yangxyue@mail.sysu.edu.cn+86 13809800195

Outcome results

None listed

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