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

NCT ID: NCT05665868

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nursing Caries Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group based on integrated care mode

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.

Group Type EXPERIMENTAL

integrated care mode

Intervention Type DEVICE

The information system consists of big data platform and nursing strategy platform. The system includes medical work end, patient operation end and administrator management end. The big data platform can automatically extract patient data from HIS, Medcare and other patient diagnosis and treatment systems, complete registration and establish patient health files according to the preset patient registration standards. By comparing the data input on the patient side with the database set on the platform, the system decision-making module can generate personalized measures and plans for feedback to patients, and can generate patient information overview feedback to the nurse side. Complete intelligent push of symptom management decision model

Control group based on conventional care mode

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.

Group Type ACTIVE_COMPARATOR

conventional care mode

Intervention Type DEVICE

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.

Interventions

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integrated care mode

The information system consists of big data platform and nursing strategy platform. The system includes medical work end, patient operation end and administrator management end. The big data platform can automatically extract patient data from HIS, Medcare and other patient diagnosis and treatment systems, complete registration and establish patient health files according to the preset patient registration standards. By comparing the data input on the patient side with the database set on the platform, the system decision-making module can generate personalized measures and plans for feedback to patients, and can generate patient information overview feedback to the nurse side. Complete intelligent push of symptom management decision model

Intervention Type DEVICE

conventional care mode

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Chen, Bachelor

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Chen, Bachelor

Role: CONTACT

Phone: (+86)13770336619

Email: [email protected]

Zhijian Liu, Doctor

Role: CONTACT

Phone: (+86)15951814859

Email: [email protected]

Facility Contacts

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Li Chen, Bachelor

Role: primary

Other Identifiers

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2022-LCYJ-MS-30

Identifier Type: -

Identifier Source: org_study_id