melanoma
Conditions
Interventions
control group:anti-PD-1 therapy
experimental group:anti-PD-1 therapy and psychological intervention
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Aged = 2 weeks. The postoperative recovery is good, and the postoperative stage is stage III. 4. Mild to moderate depressive disorder (PHQ-9: 5 ~ 14 points) or mild to moderate anxiety disorder (GAD-7: 5 ~ 14 points). 5. It is allowed to have received systematic antitumor drugs in the past, but all relevant toxic events have returned to normal or grade I or below specified in CTCAE 4.03, except hair loss. 6. The ECoG score was 0 ~ 1. 7. Organ function level must meet the following requirements (7 days before enrollment): (1) Bone marrow: absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet (PLT) >= 100 x 10^9 / L, hemoglobin (HB) >= 9 g / dl (no blood transfusion or component blood received within 14 days before the test); (2) Liver: serum bilirubin (TBIL) = 50 ml / min. According to Cockcroft Gault formula, CrCl = [(140 age) * body weight (kg) * (0.85, female only)] / (72 * serum creatinine)]; (4) International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal value (this clause is only applicable to patients who have not received anticoagulant therapy; For patients receiving anticoagulant therapy, the anticoagulant should be within the range of treatment requirements); (5) Normal or abnormal FT3, FT4 and TSH have no clinical significance or received endocrine therapy. 8. Those who meet the indication of PD-1 antibody adjuvant therapy and agree to receive PD-1 antibody adjuvant therapy. 9. Ability to read and complete the questionnaire independently. 10. The subjects volunteered to join the study, with good compliance and follow-up. 11. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous or current diagnosis of depression (PHQ-9 >= 15, or suicidal tendency (behavior)), anxiety disorder (GAD-7 >= 15, or suicidal tendency (behavior)), previous diagnosis of other major mental disorders or cognitive disorders (such as dementia). 2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 3. Major surgery was performed / received within 2 weeks before enrollment, or had not recovered from the side effects of surgery and live vaccination. 4. Patients who received hematopoietic stimulating factors, such as granulocyte colony stimulating factor (G-CSF) and erythropoietin, within 1 week before enrollment. 5. HIV antibody or Treponema pallidum antibody (tested for Treponema pallidum antibody titer in class III class A hospitals including the research center) was positive. 6. The following situations occurred within 6 months before joining the group: Miocardial infarction; Severe or unstable arrhythmia or angina pectoris; Percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism. 7. The patient has any situation that affects the subject's swallowing of the drug and any situation that affects the disposal process (absorption, distribution, metabolism or excretion) of the drug in the body, including any kind of gastrointestinal resection or surgical history. 8. He has received stem cell transplantation or organ transplantation. 9. Patients who used the following drugs within 14 days before enrollment or during treatment: CYP3A4 strong inhibitor or strong inducer; Warfarin or any other coumarin derivative anticoagulant. 10. Currently taking psychotropic substances. 11. Other severe, acute or chronic medical diseases or laboratory abnormalities that the investigator judges may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results. 12. The investigator judged that the patients with poor compliance or other conditions were not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| depression score;anxiety score; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence free survival;quality of life score;anti-PD-1 therapy related adverse events; | — |
Countries
China
Contacts
Public ContactLi Jingjing
Sun Yat-Sen University Cancer Center
Outcome results
None listed