NCT07201441

Brief Summary

Research data show that the incidence of bladder tumors in China ranks first among malignant tumors of the urinary system and is on the rise . Muscle - invasive bladder tumor is a fatal malignant tumor, and radical cystectomy with urinary diversion is the main treatment method . After urinary diversion, patients rely on urostomy for urination for life, unable to control urine at will, and need to wear ostomy bags for life, resulting in self - image disorder. Urostomy brings a lot of troubles to patients and their families, increases the economic burden, especially makes young patients feel anxious about life, lose confidence in the future, and causes great psychological pressure . Due to the strong professionalism of stoma care, with the improvement of medical technology, the average hospital stay of patients after surgery is shortened, resulting in patients not fully mastering the knowledge and skills of urostomy care at the time of discharge, and their self - care ability is at a low level. They are prone to various health problems, which directly affects the quality of life of patients and their families . Health is an inevitable requirement for the all - around development of people. The "Healthy China 2030" Plan Outline emphasizes the concept of proactive health. Proactive health refers to long - term, continuous and dynamic tracking of an individual's behavior system, identification and assessment of one's own state, evolution direction and degree, selection of various elements of lifestyle as the main means, giving full play to one's subjective initiative, and conducting controllable interventions on human behavior to improve health behaviors. In 2017, the Ministry of Science and Technology issued a notice officially including proactive health in the special plan. The concept of proactive health management has become an important part of realizing the Healthy China strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 31, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

September 23, 2025

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Urostomy Self - care Score Urostomy Self - care Score Urostomy Self - care Score

    Developed by Kristensen , it includes 2 dimensions and 7 items. Each item is divided into 4 levels, scored from 0 to 3 points, with a total score ranging from 0 to 21 points. The higher the score, the higher the patient's self - care level. In 2014, Fu Suliang translated this scale into Chinese and tested its reliability and validity. The content validity index of the Chinese version of the Urostomy Self - care Scale is 0.952, and the Cronbach α coefficient is 0.88. It is suitable for measuring the self - care ability of patients with urostomy.

    The 1st, 3rd, and 6th months after surgery

Secondary Outcomes (1)

  • Anxiety State Score

    The 1st, 3rd, and 6th months after surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

On the basis of routine nursing, the intelligent cloud platform management mode is added.

Behavioral: Smart Nursing Based on the Health Cloud Platform

Control Group

ACTIVE COMPARATOR

Implement routine nursing.

Behavioral: Smart Nursing Based on the Health Cloud Platform

Interventions

On the day of surgery, ensure that the patient or their family members have followed the hospital's official account and bound the patient's information. Through the intelligent cloud platform on the mobile device, they can query the patient's inpatient information, such as examination reports and details of inpatient expenses, and also consult and communicate about the patient's condition.

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those with clear consciousness, distinct self - expression and without mental abnormalities.
  • Individuals whose age is between 18 and 80 years old (inclusive), and whose self - care ability (Barthel Index) score is greater than 90 points.
  • Those who are clearly aware of the diagnosis and have undergone total cystectomy with urostomy.
  • Patients without depression. Patients or their family members are able to use WeChat. Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

  • Patients with tumor metastasis or combined with other tumors. Those with visual impairment. Vulnerable groups, including patients with mental illnesses, those with cognitive impairment, critically ill patients, minors, pregnant women, illiterate people, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

January 31, 2023

Primary Completion

May 12, 2025

Study Completion

September 20, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations