Clinical trial NCT05665868: Study on Integrated Nursing Strategy for Patients With Gastrointestinal Stromal Tumors After Targeted Therapy
Official title: The Construction and Empirical Study of Symptom Management and Integrated Care Strategy for Gastrointestinal Stromal Tumor Patients With Targeted Therapy Based on MRC Framework
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursing Caries
Gastrointestinal Stromal Tumors
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scoring of quality of life using the cancer treatment function evaluation system
timeFrame: One month after intervention
measure: Scoring of quality of life using the cancer treatment function evaluation system
timeFrame: Three month after intervention
measure: Scoring of quality of life using the cancer treatment function evaluation system
timeFrame: Six month after intervention
measure: Quality of life score of patients assessed by the specific module of gastric cancer of Anderson Symptom Assessment Scale
timeFrame: One month after intervention
measure: Quality of life score of patients assessed by the specific module of gastric cancer of Anderson Symptom Assessment Scale
timeFrame: Three month after intervention
measure: Quality of life score of patients assessed by the specific module of gastric cancer of Anderson Symptom Assessment Scale
timeFrame: Six month after intervention
measure: Anxiety tendency of patients in the past week assessed by self rating anxiety scale
timeFrame: One month after intervention
measure: Anxiety tendency of patients in the past week assessed by self rating anxiety scale
timeFrame: Three month after intervention
measure: Anxiety tendency of patients in the past week assessed by self rating anxiety scale
timeFrame: Six month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Li Chen, Bachelor
role: STUDY_CHAIR
References: