Developing and Testing the Effectiveness of Smart Healthcare Assisted Individualized Symptom Management Education and Home-based Exercise on Frailty, Treatment-related Adverse Events and Quality of Life in Advanced Gastric Cancer Patients Receiving Immunotherapy
2026년 7월 23일 업데이트: Taipei Veterans General Hospital, Taiwan
The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and quality of life in advanced gastric cancer patients receiving immunotherapy. The main questions it aims to answer are:
- Can AI-ISME&HE reduces frailty in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME&HE increases quality of life in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME&HE increases self-efficacy in advanced gastric cancer patients receiving immunotherapy?
- Can AI-ISME&HE reduces all-caused death in advanced gastric cancer patients receiving immunotherapy within two years? Researchers will compare usual routine care to see if AI-ISME&HE can reduce frailty, all-caused death and increase quality of life and self-efficacy.
Participants will not be blinded, but the outcome evaluator will be blinded. The participants will be asked to complete three tasks for 12 weeks:
- Self-reporting treatment-related adverse events
- Interacting with AI-ISME&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty
- ViviFrail-based exercise
연구 개요
연구 유형
중재적
등록 (추정된)
110
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Shiow-Ching Shun, PhD
- 전화번호: +886911268998
- 이메일: scshun@nycu.edu.tw
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- age ≥18 years
- diagnosed as AGC (TNM: T2~T4, N>0, Any M, Stage: III~IV, or unresectable GC)
- scheduled to receive the first cycle of immunotherapy
- willingness to provide written informed consent after receiving a full explanation of the study
Exclusion Criteria:
- a diagnosis of another type of cancer within the past five years
- inability to communicate clearly
- a diagnosis of dementia
- acute pulmonary embolism
- acute myocardial infarction
- extremity bone fracture within the past three months
- bone metastasis
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention
AI-ISME&HE intervention group
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간섭 없음: Control
Usual routine care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
The SPPB score from 0-12 points, with 10-12 indicating robust, 7-9 indicating prefrail, and 4-6 indicating frail.
It has good reliability (ICC range from 0.82-0.92)
and validity.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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Level of Frailty Assessed by Comprehensive Geriatrics Assessment
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
A total of 8 domains were used to comprehensively assess frailty in cancer patients: Functional status, Comorbidity, Nutrition, Polypharmacy, Social support, Cognition, and Mood. 0 abnormal domains indicate robust, any 1 abnormal indicates pre-frail, and 2 or more abnormality indicate frailty. Each domain can be assessed by different tools. In this study, we chose the tools according as follows:
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Frailty Assessed by Geriatric 8 (G8)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
The G8 score from 0-17 points, with score ≤14 indicating frailty.
It has good sensitivity (86.9%) in cancer patients
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
The TCFT score from 0-5 points, with score >0 indicating frailty.
It has good ROC values of 0.857 in cancer patients
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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It includes 7 items and compromised physical well-being (3 items), emotional well-being (1 items), and functional well-being (3 items).
The score of each item is from 0 (not at all) to 5 (very much), and the total score ranging from 0 to 28, with a higher score indicating better quality of life.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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It is a 0-10 Likert-type scale, where 0 indicates no confidence at all and 10 indicates fully confidence.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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All Cause Mortality After 2 Year Follow-up
기간: Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
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The survival status of the patients will be followed by medical record.
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Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
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Level of Symptom Severity Assessed by The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
The 14 symptoms include fatigue, headache, shortness of breath, nausea/vomiting, rash, diarrhea, decreased appetite, numbness/tingling, general pain, blurred vision, constipation, abdominal pain, itching, and dizziness.
Symptoms are assessed by using five-point Likert-type scale to rate symptom frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), and interference (not at all, a little bit, somewhat, quite a bit, very much) in the past 7 days.
It can composite grading based on an algorithm into grade 0 to 3.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Nutrition Status Assessed by The Mini Nutritional Assessment Short Form (MNA-SF)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
It includes 6 items relating to food intake in the past three months, weight loss in the past three months, physical activity, stress, dementia or depression, and body mass index (BMI).
The total score ranges from 0-14, with 12-14 representing well, 8-11 representing at risk, and 0-7 representing malnutrition.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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The scale consists of 12 items with a total score ranging from 0 to 30, assessing cognitive function across eight domains, including visuospatial construction, executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.
A score of 24 below indicates cognitive impairment.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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PHQ-9 is a depression muddle from the complete PHQ, including nine DSM-IV criteria for depression, each item scores from 0-3, with a total score range from 0-27.
A higher score indicates higher severity of depression, with a score 0-4 as none, 5-9 as mild, and ≥ 10 as moderate-severe depression.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Level of Physical Function Assessed by Grip Strength (GS)
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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GS will be assessed by JAMAR hydraulic dynamometer, which show good reliability.
The participants will be asked to sit in the neutral position with their elbows flexed at 90° and resting at their sides.
Next, they need to squeeze the handle of the dynamometer for 3-5 seconds as hard as possible for 3 trials on dominant hand with a rest of 60 seconds.
The average and the maximum of the grip strength (kg) will be recorded.
Female with GS ≤ 16 kg and male ≤ 26.7 kg refer to frailty.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Changes of Body Composition Assessed by Body Composition Machine
기간: Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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Body composition will be examined by ACCUNIQ BC300 which is a lightweight, foldable professional body composition analyzer that utilizes bioelectrical impedance analysis (BIA) technology.
Through eight electrodes and three different frequencies (5, 50, 250 kHz), it performs full-body and segmented (arms, legs, torso) measurements, quickly providing detailed data such as body fat, muscle mass, and water content with high accuracy within 5 minutes.
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Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: I-Wen Chang, PhD, Department of Nursing, Taipei Veterans General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 21일
기본 완료 (추정된)
2029년 7월 31일
연구 완료 (추정된)
2030년 7월 31일
연구 등록 날짜
최초 제출
2026년 7월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
2026년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .