Oral CancerNCT07562100
Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer
A study testing Prehabilitation application, Conventional physiotherapy and Scar management in people with Oral Cancer and Psychological Distress, run by Taipei Veterans General Hospital, Taiwan at 5 sites in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Psychological Distress, Communication Aids for Disabled
- What is being tested?
- Prehabilitation application, Conventional physiotherapy and Scar management
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 5 sitesTaiwan
- Study dates
- 27 Sep 2024to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Risk populations for walking or performing exercise
- Patients with cognitive impairment or psychiatric diseases
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 110
Yueh-Hsia Chen, PhD, +886-921435981, yuehhsiachen@ntu.edu.tw
- Enrolling by invitation
National Yang Ming Chiao Tung University
Taipei, 112
- Recruiting
National Yang Ming Chiao Tung University
Taipei, 112
Yong-Sheng Chen, +886-975775064, yschen@nycu.edu.tw
- Recruiting
National Yang Ming Chiao Tung University
Taipei, 112
Yu-Chi Chen, PhD, +886-958911922, ycchen2@nycu.edu.tw
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Muh-Hwa Yang, PhD, +886-2-28267000 #66510, mhyang2@nycu.edu.tw
About this study
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?
Read more
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.
- Conditions
- Oral Cancer, Psychological Distress, Communication Aids for Disabled, Physiotherapy, Return to Work, Prehabilitation
- Being tested
- Prehabilitation application, Conventional physiotherapy, Scar management, AI-based physiotherapy
- Keywords
- Artificial Intelligence, Return to Work, Oral Cancer, Psychological Distress, Communication Aids for Disabled, Physiotherapy, Prehabilitation, Physical symptom distress, motor function, Rehabilitation, Quality of life, Cost effectiveness, prediction model, case management, APP(Application)
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation applicationDevice
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.
Conventional physiotherapyBehavioural
jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks
Scar managementBehavioural
scar massage and jaw-mobilizing exercises combined with devices or depressors
AI-based physiotherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Conventional physiotherapy; Behavioral: Scar management |
| Intervention group | Experimental | The patients in this group will receive and use AI APP while receiving usual care. Receives: Device: Prehabilitation application; Behavioral: Scar management; Behavioral: AI-based physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
Secondary outcomes (5)
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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months after surgery, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start27 Sep 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital, National Yang Ming Chiao Tung University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562100
- Sponsor's protocol ID
- 2024-03-011BC
- Other IDs
- NSTC 113-2314-B-A49 -076 -, NSTC 114-2314-B-A49 -016 -, NSTC 113-2314-B-A49 -077 -, NSTC 114-2314-B-A49 -017 -, NSTC 113-2314-B-002 -298 -, NSTC 113-2314-B-A49 -078 -, NSTC 114-2314-B-002 -044 -, NSTC 114-2314-B-A49 -018 -
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer
- ClinicalTrials.gov ID
- NCT07562100
- Acronym / sponsor ID
- 2024-03-011BC
- Conditions
- Oral Cancer, Psychological Distress, Communication Aids for Disabled, Physiotherapy, Return to Work, Prehabilitation
- Keywords
- Artificial Intelligence, Return to Work, Oral Cancer, Psychological Distress, Communication Aids for Disabled, Physiotherapy, Prehabilitation, Physical symptom distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Taiwan University Hospital, National Yang Ming Chiao Tung University Hospital
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group Usual care | Active comparator | Behavioral: Conventional physiotherapy, Behavioral: Scar managementThe patients in this group will not use the AI APP. They will receive 12 times of physiotherapy and keep receiving usual care. |
| Intervention group | Experimental | Device: Prehabilitation application, Behavioral: Scar management, Behavioral: AI-based physiotherapyThe patients in this group will receive and use AI APP while receiving usual care. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Risk populations for walking or performing exercise
- Patients with cognitive impairment or psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation applicationParticipants 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. | Device | Intervention group |
| Conventional physiotherapyjaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks | Behavioural | Control group Usual care |
| Scar managementscar massage and jaw-mobilizing exercises combined with devices or depressors | Behavioural | Control group Usual care, Intervention group |
| AI-based physiotherapyjaw, 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 | Behavioural | Intervention group |
Primary outcome
Returning to work (RTW)
Time frame: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
A self-designed structured Employment status with one item collecting patients working status of "not employed", "part-time", or "full-time".
Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire
Time frame: 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 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.
Change of the level of distress on Distress Thermometer (DT) questionnaire
Time frame: 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.
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.
Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire
Time frame: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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.
Change from baseline in maximal mouth opening
Time frame: 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.
Average maximal mouth opening measured 3 times in mm
Change from baseline in shoulder joint range of motion
Time frame: 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.
Average range of motion of shoulder abduction measured 3 times in degrees
Change of the level of self efficacy on the Cancer Behavior Inventory (CBI) questionnaire
Time frame: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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.
Change of the level of health engagement on the Patient Health Engagement (PHE) questionnaire
Time frame: 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.
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.
Change of the level of perceived voice handicap on the Voice Handicap Index-10 (VHI-10) questionnaire
Time frame: 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.
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).
Change of the level of communication quality on the Communication Quality Assessment questionnaire
Time frame: 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.
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.
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
Time frame: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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.
5 secondary outcomes
Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
Time frame: 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 health-related function on EORTC QLQ-C30 questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months after surgery, and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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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Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation application, Conventional physiotherapy and Scar management in people with Oral Cancer and Psychological Distress, run by Taipei Veterans General Hospital, Taiwan at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiow-Ching Shun (+886-911-268-998, scshun@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Returning to work (RTW) (time frame: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.