Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer
2026년 4월 24일 업데이트: Taipei Veterans General Hospital, Taiwan
The goal of this clinical trial is to develop and evaluate an Artificial Intelligence Assisted Prehabilitation Program (AI APP) for returning to work and cost-effectiveness analysis in patients with oral cancer (OC). The main questions it aims to answer are:
- What kinds of needs are related to returning to work (RTW) in patients with OC from diagnosis to survival that we can incorporate into the development of AI APP to assist this population ?
- How is the effect of the AI APP that based on findings from the first question for patients with OC on physical and psychological distress, fear of recurrence, self-efficacy in coping with cancer, communication, motor function, quality of life, and RTW?
- How is the effect of the RTW AI prediction model to identify high-risk groups ? And how is the comprehensive cost effectiveness of benefits and quality of life of the AI APP for OC population?
Researchers will compare patients without using AI APP to see if the AI APP works to assist with coping physical and psychological distress, communication, motor function, quality of life, and RTW issues for individuals with OC?
Participants will:
- Be asked to fulfill a structural questionnaire, or engage in a semi-structured one-by-one interview or a focus group to assess their physical, psychological, and social support needs in the first stage.
- Be invited to participant the pilot testing of AI APP in the second stage.
- Be provided and trained by 3-month AI APP for 3 months or cared as usual in the third stage.
- Complete a structural questionnaire and follow up one year, including the baseline (before using the AI app) and at 1-2 weeks, 3 months, 6 months, 9 months, and 12 months after the baseline.
- Engage in one-by-one interview or a focus group to assess user experiences of the AI APP.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
650
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
- 전화번호: +886-911-268-998
- 이메일: scshun@nycu.edu.tw
연구 장소
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Taipei, 대만, 112
- 모병
- Taipei Veterans General Hospital
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연락하다:
- Muh-Hwa Yang, PhD
- 전화번호: +886-2-28267000 #66510
- 이메일: mhyang2@nycu.edu.tw
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Taipei, 대만, 112
- 모병
- National Yang Ming Chiao Tung University
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연락하다:
- Yu-Chi Chen, PhD
- 전화번호: +886-958911922
- 이메일: ycchen2@nycu.edu.tw
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Taipei, 대만, 110
- 모병
- National Taiwan University Hospital
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연락하다:
- Yueh-Hsia Chen, PhD
- 전화번호: +886-921435981
- 이메일: yuehhsiachen@ntu.edu.tw
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Taipei, 대만, 112
- 초대로 등록
- National Yang Ming Chiao Tung University
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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
예
설명
Inclusion Criteria:
- Adult (> 20 years old and younger than 70 years old)
- Newly diagnosed as OC and scheduled to receive cancer-related treatment
- Able to use Mobile phone
- Willing to sign an informed consent form after receiving a detailed explanation of the study's aims and procedures
- Healthcare professionals involved in patients' care, including doctors, nurses, case managers, dietitians, rehabilitation therapists, and psychologists
- Family members who are primary caregivers of the participating patients, engaged in different stages of medical care
Exclusion Criteria:
- Risk populations for walking or performing exercise
- Patients with cognitive impairment or psychiatric diseases
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Control group Usual care
The patients in this group will not use the AI APP.
They will receive 12 times of physiotherapy and keep receiving usual care.
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장치나 감압기를 결합한 흉터 마사지 및 턱 동원 운동
턱, 목, 어깨 ROM 운동, 견갑골 중심 운동, 30분 중재, 주 1회, 총 12주
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실험적: Intervention group
The patients in this group will receive and use AI APP while receiving usual care.
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턱, 목, 어깨 ROM 운동, AI 기술을 활용한 견갑골 중심 운동, 주 1회 30분 개입, 총 12주
장치나 감압기를 결합한 흉터 마사지 및 턱 동원 운동
Participants will use an Artificial Intelligence Assisted Prehabilitation Program Application (AI Assisted Prehabilitation APP, AI APP), including Generative AI Assisted Psychosocial Support chat, AI-Based Postural Correction Programs Physiotherapy Prehabilitation, and Intelligent Learning-Based Communication Navigation Assistance System to assist individuals with OC dealing with their physical and psychological distress, motor function and communication issues, and social support throughout prehabilitaion and rehabilitation to help them better returning to work.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Returning to work (RTW)
기간: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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A self-designed structured Employment status with one item collecting patients working status of "not employed", "part-time", or "full-time".
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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The Symptom Severity Scale (SSS): This scale is used to assess the severity of symptoms in cancer patients, demonstrating good validity through testing in HNC patients [30].
It includes 13 items of common symptoms among cancer patients, including swallowing difficulty, eating difficulty, oral mucositis, speech difficulty, fatigue, poor appetite, pain, cough, apnea, constipation, diarrhea, nausea, and vomiting.
Scores range from 0 to 10, where 0 indicates the absence of the symptom, and 10 represents the most severe symptoms.
Higher scores indicate a higher severity of symptoms.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of distress on Distress Thermometer (DT) questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Distress Thermometer (DT): It is a screening tool developed by The National Comprehensive Cancer Network® (NCCN®) to identify the clinical severity of psychological distress and specific problems causing distress among cancer patients.
The DT is a self-report one-item measure assessing the level of distress that patients have experienced in the previous week; the scale ranges from 0 (no distress) to 10 (extreme distress).
The DT consists of 36 problems answered with "no" or "yes," and it is clustered into five domains: practical problems, family problems, emotional problems, spiritual problems, and physical problems.
This scale has been validated and used in Chinese cancer patients and has shown good reliability.
It has also been validated with a good sensitivity (72.2%), specificity (80.0%), and accuracy (79.2%) in Taiwanese cancer patients.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire
기간: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF): The FCRI-SF with nine items is a self-report measure designed to evaluate the presence and severity of intrusive thoughts associated with fear of cancer recurrence (FCR).
Each item is rated on a 0 (not at all) to 4 (all the time) numerical rating scale.
The total score is the sum of the items, ranging from 0 to 36.
Higher scores indicate a higher level of FCR.
A threshold of 13 or greater was categorized for patients with FCR.
The FCRI-SF is a valid and reliable instrument in oncology patients in both English and Chinese.
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in maximal mouth opening
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Average maximal mouth opening measured 3 times in mm
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in shoulder joint range of motion
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Average range of motion of shoulder abduction measured 3 times in degrees
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of self efficacy on the Cancer Behavior Inventory (CBI) questionnaire
기간: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Cancer Behavior Inventory (CBI): This scale is used to measure cancer patients' self-efficacy during the cancer trajectory.
Heitzmann et al. (2011) further developed a short form with 14 items containing four dimensions: maintaining independence and positive attitude, participating in medical care, coping and stress management, and managing effect.
It has been translated into Chinese version by modifying the scale to an 11-point Likert scale, ranging from 0 (not at all confident) to 10 (totally confident) with good internal consistency (Cronbach's alpha=0.789)
and test-retest reliability over a week.
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of health engagement on the Patient Health Engagement (PHE) questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Patient Health Engagement (PHE): Scores are arranged in sequential order, and the median score represents the patient's level of health engagement.
Higher numbers indicate greater patient engagement.
The scale demonstrates strong validity and consistency.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of perceived voice handicap on the Voice Handicap Index-10 (VHI-10) questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Voice Handicap Index-10 (VHI-10): The Voice Handicap Index (VHI) was designed to assess the impact of voice disorders on quality of life.
Original form comprises 30 items across functional, physical, and emotional dimensions, a short form 10-item version was introduced in 2004.
Responses are scored on a scale from 0 (never) to 4 (always), with higher scores indicating a greater perceived voice handicap.
The Mandarin version had good substantiated validity and reliability (Cronbach's alpha= 0.934).
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of communication quality on the Communication Quality Assessment questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Communication Quality Assessment: A communication quality assessment scale was developed by the research team to evaluate the patient's communication experience across five dimensions: clarity of communication, level of understanding, problem-solving effectiveness, communication efficiency, and overall satisfaction with communication.
Each item is rated on a 5-point Likert scale (1 to 5), with higher scores indicating better communication quality.
The items can be analyzed individually to assess specific aspects of communication, or summed to generate a total score representing overall communication quality.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of health-related quality of life on the Functional Assessment of Cancer Therapy (FACT-G7) and The EuroQol instrument (EQ-5D) questionnaire
기간: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Functional Assessment of Cancer Therapy, FACT-G version 4: It has been developed to measure the health-related quality of life in cancer patients. It comprises 27 items categorized into four domains: physical (7 items), social/family (7 items), emotional (6 items), and functional well-being (7 items). It is a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much). The total score ranges from 0 to 108, with higher scores indicating a better quality of life. Its traditional Chinese version demonstrated good reliability with a Cronbach's alpha of 0.85. The EuroQol instrument, EQ-5D: It has been developed to measure the health-related quality of life. It consists of two parts. The first part includes 5 items to present 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 5 levels. The second part is a thermometer-like visual analog scale from 0 to 100. Its traditional Chinese version demonstrated good validity. |
Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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A total scale from 1 to 100.
Higher scores indicate greater disability.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in health-related function on EORTC QLQ-C30 questionnaire
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30): The questionnaire includes five functional subscales: physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning.
In addition, it assesses a range of cancer-related symptoms, including fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
Most of the items are scored on a 4-point Likert-type scale, ranging from 1 ("not at all") to 4 ("very much"), with higher scores indicating greater symptom burden or lower functioning.
Two items assess global health status/overall quality of life, scored on a 7-point Likert-type scale ranging from 1 ("very poor") to 7 ("excellent"), where higher scores reflect better quality of life.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in whole-body physical function on 6-minute walk test
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Walking distance measured in meters.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in shoulder pain
기간: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Visual analog scale from 0 to 10. Higher scores indicate most pain.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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The user experience of the APP intervention
기간: 3 months after surgery, and 6 months after surgery
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The user experience will use a self-designed questionnaire developed using the Technology Acceptance Model (TAM) and individual interview
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3 months after surgery, and 6 months after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2024년 9월 27일
기본 완료 (추정된)
2028년 7월 31일
연구 완료 (추정된)
2029년 12월 1일
연구 등록 날짜
최초 제출
2025년 2월 27일
QC 기준을 충족하는 최초 제출
2026년 4월 24일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 24일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2024-03-011BC
- NSTC 113-2314-B-A49 -076 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 114-2314-B-A49 -016 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 113-2314-B-A49 -077 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 114-2314-B-A49 -017 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 113-2314-B-002 -298 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 113-2314-B-A49 -078 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 114-2314-B-002 -044 - (기타 보조금/기금 번호: National Science and Technology Council)
- NSTC 114-2314-B-A49 -018 - (기타 보조금/기금 번호: National Science and Technology Council)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .