Clinical trial NCT05598827: Application of Douyin in Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Tumor
Chemotherapy
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Men and women aged 10-70. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Anxiety and depression
timeFrame: 24 hours before chemotherapy
measure: Anxiety and depression
timeFrame: 1 day of chemotherapy
measure: Anxiety and depression
timeFrame: 24 hours after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: