Application of Douyin in Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy

NCT05598827 | Unknown DMC

• 1 other identifier: ZZUSC-15
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Tumor; Chemotherapy

Outcome Measures

Primary Outcomes (3)

• Anxiety and depression

  Hospital Anxiety Depression Scale

  24 hours before chemotherapy

• Anxiety and depression

  Hospital Anxiety Depression Scale

  1 day of chemotherapy

• Anxiety and depression

  Hospital Anxiety Depression Scale

  24 hours after chemotherapy

Study Arms (2)

Watch the Tik Tok

EXPERIMENTAL

Unlimited Tik Tok viewing was encouraged from 24 hours before chemotherapy until the seventh day after chemotherapy.

Other: Tik Tok

Tik Tok is not allowed

NO INTERVENTION

Viewing of Tik Tok was prohibited from 24 hours before chemotherapy until the seventh day after chemotherapy.

Interventions

Tik Tok OTHER

The enrolled patients were encouraged to watch Tik Tok without limit starting 24 days before chemotherapy and continuing until the seventh day after chemotherapy.

Watch the Tik Tok

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 28, 2022
• Study Start: December 28, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share