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
2026年7月23日 更新者：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
調査の概要
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Shiow-Ching Shun, PhD
- 電話番号：+886911268998
- メール：scshun@nycu.edu.tw
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
AI-ISME&HE intervention group
|
|
|
介入なし：Control
Usual routine care
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Level of Frailty Assessed by The Short Physical Performance Battery (SPPB)
時間枠：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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Frailty Assessed by Comprehensive Geriatrics Assessment
時間枠：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:
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Frailty Assessed by Geriatric 8 (G8)
時間枠：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
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Frailty Assessed by Taiwan Cancer Frailty Tool (TCFT)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score of Quality of Life Assessed by The Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Self-efficacy Assessed by The Modified Cancer Behavior Inventory (CBI)
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
It is a 0-10 Likert-type scale, where 0 indicates no confidence at all and 10 indicates fully confidence.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
All Cause Mortality After 2 Year Follow-up
時間枠：Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
|
The survival status of the patients will be followed by medical record.
|
Record patient's survival status at baseline, 1 year after baseline, and 2 year after baseline.
|
|
Level of Symptom Severity Assessed by The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
時間枠：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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Nutrition Status Assessed by The Mini Nutritional Assessment Short Form (MNA-SF)
時間枠：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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Cognitive Function Assessed by The Montreal Cognitive Assessment (MoCA)
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Depression Assessed by The Patient Health Questionnaire-9 (PHQ-9)
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
|
Level of Physical Function Assessed by Grip Strength (GS)
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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.
|
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
時間枠：Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
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.
|
Changes from baseline, 12 weeks after baseline, and 24 weeks after baseline.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：I-Wen Chang, PhD、Department of Nursing, Taipei Veterans General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月21日
一次修了 (推定)
2029年7月31日
研究の完了 (推定)
2030年7月31日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月23日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月29日
QC基準を満たした最後の更新が送信されました
2026年7月23日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。