To Observe a Single-center, Randomized, Controlled Clinical Study on the Effect of Douyin on the Emotions of Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Anxiety and depression
研究概览
简要总结
A total of 90 patients with bone and soft tissue malignancies who planned to receive chemotherapy were enrolled in this study in Henan Cancer Hospital. They were divided into experimental group and control group for anxiety and depression value 24 hours before chemotherapy, anxiety and depression value on the day of chemotherapy, anxiety value and depression value 24 hours after chemotherapy. To evaluate the effects of watching Tik Tok on perichemotherapy anxiety and depression in patients with bone and soft tissue malignant tumors who were to receive chemotherapy, and to evaluate the effects of watching Tik Tok on the incidence of chemotherapy-related complications in patients with bone and soft tissue malignant tumors who were to receive chemotherapy.
详细描述
A total of 90 patients with bone and soft tissue malignancies who were scheduled to receive chemotherapy were enrolled in this study in Henan Cancer Hospital. They were divided into experimental group and control group: experimental group: Patients enrolled in this study were encouraged to watch Tik Tok without limit from 24 hours before chemotherapy to the seventh day after chemotherapy. Control group: Viewing Tik Tok was forbidden from 24 hours before chemotherapy to the seventh day after chemotherapy. Anxiety and depression 24 hours before chemotherapy, anxiety and depression 24 hours after chemotherapy, and anxiety and depression 24 hours after chemotherapy. To evaluate the effects of watching Tik Tok on perichemotherapy anxiety and depression in patients with bone and soft tissue malignant tumors who were to receive chemotherapy, and to evaluate the effects of watching Douyin on the incidence of chemotherapy-related complications in patients with bone and soft tissue malignant tumors who were to receive chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 10-
- •The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-
- •Subjects with amputation can be relaxed up to 2 points.
- •Pathological diagnosis of bone and soft tissue malignancy. Patients who have received at least one previous chemotherapy and are planning to receive new chemotherapy.
- •All acute toxicities from previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE, version 4.03) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), with the exception of toxicities such as hair loss that the investigator considered to pose no safety risk to the subject).
- •Adequate organ and bone marrow function, as defined below:
- •Blood routine (no blood transfusion, no G-CSF, no medication correction within 7 days before screening) :
- •Neutrophil count (ANC)≥1,500/mm3(1.5×109/L); Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);
- •Blood biochemical:
- •Serum creatinine (Cr)≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;
- •Blood coagulation function:
- •International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN; With my consent and signed informed consent, I am willing and able to comply with the planned visit, study treatment, laboratory tests and other test procedures.
排除标准
- •Received the following treatment within 7 days before C1D1:
- •Radiotherapy, chemotherapy, immune or molecularly targeted therapy for tumors. Some other investigational drugs. Surgery for other sites and/or radiotherapy were planned during the study period (24 hours before chemotherapy and 7 days after chemotherapy).
- •Imaging diagnosis showed the presence of central nervous system tumor lesions. The presence of active heart disease in the 6 months before C1D1, including myocardial infarction, severe/unstable angina pectoris, etc. Poorly controlled arrhythmias with left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).
- •In the judgment of the investigator, there are concomitant diseases (such as severe diabetes, neurological or psychiatric diseases) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or affect the completion of the study.
结局指标
主要结局
Anxiety and depression
时间窗: 24 hours after chemotherapy
Hospital Anxiety Depression Scale
次要结局
未报告次要终点
研究者
Wang Jiaqiang
associate chief physician
Henan Cancer Hospital