Study on Integrated Nursing Strategy for Patients With Gastrointestinal Stromal Tumors After Targeted Therapy

Nanjing University

Status: Enrolling

Conditions: Gastrointestinal Stromal Tumors; Nursing Caries

Treatments: Device: integrated care mode; Device: conventional care mode

Study type: Interventional

Funder types: Other

Identifiers

NCT05665868

2022-LCYJ-MS-30

Details and patient eligibility

About

The goal of this clinical trial is to construct a symptom management strategy for patients with gastrointestinal stromal tumor targeted therapy based on symptom management theory under the guidance of MRC framework. Embed the symptom management strategy into the information platform and conduct an empirical study on integrated care for GIST patients, and compare it with the traditional outpatient follow-up patients to explore the safety and effectiveness of the symptom management strategy and the application effect of the integrated care platform.

Full description

The purpose of this clinical trial is to build an information platform for symptom management and integrated care strategy of gastrointestinal stromal tumor targeted treatment patients: the system is composed of big data platform and care strategy platform. The big data platform can automatically extract patient data from HIS, Medcare and other patient diagnosis and treatment systems according to the pre-set patient inclusion criteria, form a health file of gastrointestinal stromal tumor targeted treatment patients, and complete the enrollment. The system will intelligently promote the care strategies of the patients included in the big data platform, promote the two-way communication between doctors and patients, and realize the functions of timed symptom evaluation, symptom management, symptom management result feedback, etc. All patient health data can be customized output through the big data platform. The two platforms complement each other, promote patient self-management, improve the quality of medical follow-up service, reduce the workload of medical personnel, optimize the use of medical resources, and improve the quality of scientific research data. It is not necessary for patients to judge how to take intervention measures, but the system's management center decision-making module will evaluate the symptoms of patients, and then pop up corresponding measures, so that patients can more effectively cope with the discomfort of related symptoms caused by targeted treatment at home, and alleviate the impact on life.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as gastrointestinal stromal tumor and receiving targeted therapy

  • Over 18 years old, with normal communication ability

    • Will use smart phones, or the family members who will use smart phones will live in the meeting

      • Informed consent and voluntary participation in this study.

Exclusion criteria

• Patients with psychiatric history or congenital mental retardation

  • The patient or his/her cohabiting family members cannot complete the health status self test, health status assessment and questionnaire under the prompts of the platform.

Criteria for case termination:

• Those who voluntarily put forward termination during the study period and are unwilling to accept follow-up or refuse to fill in the questionnaire

  • Death

    • Lost subjects

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Experimental group based on integrated care mode

Experimental group

Description:

① Obtain the health records of patients receiving targeted treatment of gastric stromal tumors in the big data platform; ② Patients upload health data, disease symptoms, complete questionnaires, health consultation and other functions; ③ The platform can regularly send audit reminders, automatically analyze the data uploaded and saved by patients, automatically and intelligently intervene when abnormal results occur, and remind medical staff to intervene manually; ④ Researchers can view the recent health status of patients through the terminal, and members of corresponding disciplines can give targeted health guidance according to the existing health problems of patients; Remind patients with complex conditions to have outpatient reexamination; ⑤ Push disease related knowledge every week for patients to learn independently.

Treatment:

Device: integrated care mode

Control group based on conventional care mode

Active Comparator group

Description:

① The health education manual for patients receiving targeted treatment of gastric stromal tumors will be issued. The patients who need targeted treatment will be identified and followed up in the routine outpatient department (1 month, 3 months, 6 months, 12 months after surgery, and once a year thereafter); ② Telephone follow-up (1 month, 3 months, 6 months, 12 months and once a year thereafter); ③ Patients independently complete disease symptom monitoring, lifestyle adjustment, and other disease self-management.

Treatment:

Device: conventional care mode