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Effectiveness of Digital Therapeutics for the Perioperative Management in Patients Undergoing Lung Cancer Resection: An Open-Label, Non-Inferiority, Randomised Controlled Trial

Effectiveness of Digital Therapeutics for the Perioperative Management in Patients Undergoing Lung Cancer Resection: An Open-Label, Non-Inferiority, Randomised Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064723
Enrollment
Unknown
Registered
2022-10-15
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Multidisciplinary Management Group:Routine preoperative health education and the standard of nursing+Treatment aimed at promoting the reexpansion of the operative lung
Digital Therapeutics Group:In addition to receiving routine care, digital software (digital therapy) was used for management, and preoperative health education video course was completed to improve pa

Sponsors

The First Affiliated Hospital, Zhejiang University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years; 2. Patients planning to undergo minimally invasive pulmonary resection surgery; 3. The measured value of FEV1 in preoperative lung function examination is greater than or equal to 1.2L, and greater than or equal to 60% of the expected value; 4. Have received high school (including technical secondary school) education or above, and have the ability to use intelligent devices and fill out electronic questionnaires; 5. Clearly aware, without reading, communication, or cognitive impairment, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Smoking cessation time before surgery is less than 2 weeks; 2. The preoperative patient's functional condition score (ECOG score) is greater than 1 point; 3. Patients who have received preoperative neoadjuvant therapy; 4. Patients who have undergone chest surgery in the past; 5. Patients who are unable to move due to organic changes such as trauma or illness, such as severe arthritis; 6. There is evidence to suggest continuous use of systemic corticosteroids within one month prior to surgery; 7. At the beginning of the study treatment, any unresolved toxicity from previous treatment was greater than CTCAE level 1; 8. Previous history of major diseases, including a history of other malignant tumors within 5 years, and a 6-month history of angina, myocardial infarction, and stroke; 9. There is evidence indicating the current existence of serious or uncontrollable systemic diseases, including thyroid disease, uncontrollable hypertension, coagulation dysfunction or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); 10. According to the judgment of the researcher, there are other situations where the patient is not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
FEV1% recovery rate;

Secondary

MeasureTime frame
length of stay;adverse event rate;90-day readmissions rate;symptome burden score;satisfaction;

Countries

China

Contacts

Public ContactJian Hu

First Affiliated Hospital of Zhejiang University School of Medicine

dr_hujian@zju.edu.cn+86 571 87236847

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026