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| ID | Type | Description | Link |
|---|---|---|---|
| NSTC 113-2314-B-A49 -076 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 114-2314-B-A49 -016 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 113-2314-B-A49 -077 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 114-2314-B-A49 -017 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 113-2314-B-002 -298 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 113-2314-B-A49 -078 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 114-2314-B-002 -044 - | Other Grant/Funding Number | National Science and Technology Council | |
| NSTC 114-2314-B-A49 -018 - | Other Grant/Funding Number | National Science and Technology Council |
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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| National Yang Ming Chiao Tung University Hospital | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group Usual care | Active Comparator | 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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| Intervention group | Experimental | The patients in this group will receive and use AI APP while receiving usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation application | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Returning to work (RTW) | A self-designed structured Employment status with one item collecting patients working status of "not employed", "part-time", or "full-time". | Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery. |
| Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire | 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. | 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. |
| Change of the level of distress on Distress Thermometer (DT) questionnaire | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire | A total scale from 1 to 100. Higher scores indicate greater disability. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiow-Ching Shun | Contact | +886-911-268-998 | scshun@nycu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 110 | Taiwan |
Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
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| Conventional physiotherapy | Behavioral | jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks |
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| Scar management | Behavioral | scar massage and jaw-mobilizing exercises combined with devices or depressors |
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| AI-based physiotherapy | Behavioral | jaw, neck, shoulder ROM exercises, and scapular-focused exercises guided by AI technology, 30 minutes of intervention, once a week, and a total of 12 weeks |
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| Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire | 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. | Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery. |
| Change from baseline in maximal mouth opening | Average maximal mouth opening measured 3 times in mm | 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. |
| Change from baseline in shoulder joint range of motion | Average range of motion of shoulder abduction measured 3 times in degrees | 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. |
| Change of the level of self efficacy on the Cancer Behavior Inventory (CBI) questionnaire | 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. | Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery. |
| Change of the level of health engagement on the Patient Health Engagement (PHE) questionnaire | 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. | 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. |
| Change of the level of perceived voice handicap on the Voice Handicap Index-10 (VHI-10) questionnaire | 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). | 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. |
| Change of the level of communication quality on the Communication Quality Assessment questionnaire | 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. | 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. |
| 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 | 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. |
| Change from baseline in health-related function on EORTC QLQ-C30 questionnaire |
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. |
| 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. |
| Change from baseline in whole-body physical function on 6-minute walk test | Walking distance measured in meters. | 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. |
| Change from baseline in shoulder pain | Visual analog scale from 0 to 10. Higher scores indicate most pain. | 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. |
| The user experience of the APP intervention | The user experience will use a self-designed questionnaire developed using the Technology Acceptance Model (TAM) and individual interview | 3 months after surgery, and 6 months after surgery |
| National Yang Ming Chiao Tung University | Enrolling by invitation | Taipei | 112 | Taiwan |
| National Yang Ming Chiao Tung University | Recruiting | Taipei | 112 | Taiwan |
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| National Yang Ming Chiao Tung University | Recruiting | Taipei | 112 | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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