NCT05598229

Brief Summary

Fitting into the group of 90 cases of this study was to henan tumor hospital bone prosthesis replacement of surgical treatment of bone malignant tumors patients, evaluate watch trill to be bone prosthesis replacement surgery treatment of malignant bone tumor patients perioperative anxiety, depression, pain, explore watch trill to bone prosthesis replacement surgery treatment of malignant bone tumor patients of postoperative complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 28, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 7, 2024

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 23, 2022

Last Update Submit

February 5, 2024

Conditions

Malignant Tumor of BonePerioperative Period

Outcome Measures

Primary Outcomes (7)

  • Visual Analogue Scale

    A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and \> 8 was classified as "poor".

    48 hours before surgery

  • Hospital Anxiety Depression Scale

    Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.

    24 hours before surgery

  • Hospital Anxiety Depression Scale

    Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.

    30 minutes before surgery

  • Hospital Anxiety Depression Scale

    Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.

    24 hours after surgery

  • Visual Analogue Scale

    A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and \> 8 was classified as "poor".

    24 hours after surgery

  • Hospital Anxiety Depression Scale

    Two subscales, anxiety and depression, were included. 0-7 were asymptomatic, 8-10 were suspicious, and 11-21 were definitely present.

    48 hours after surgery

  • Visual Analogue Scale

    A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured. In clinical evaluation, "0-2" was classified as "excellent", "3-5" was classified as "good", "6-8" was classified as "fair", and \> 8 was classified as "poor".

    48 hours after surgery

Study Arms (2)

Watch the Tik Tok

EXPERIMENTAL

Encouraged to watch the Tik Tok.

Other: Tik Tok

Tik Tok is not allowed

NO INTERVENTION

Tik Tok is not allowed.

Interventions

Tik TokOTHER

Encourage and do not restrict watching Tik Tok

Watch the Tik Tok

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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.

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 14 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 surgery to 7 days after surgery).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Wang Jiaqiang, Dr

CONTACT

13592413731wjqwtj@126.com

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 30, 2025

Study Completion

December 30, 2025

Last Updated

February 7, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share