Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer

NCT07562100 | Recruiting

• 9 other identifiers: 2024-03-011BCNSTC 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 -
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 5

Brief 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). 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.

Conditions

Oral Cancer; Psychological Distress; Physiotherapy; Return to Work; Rehabilitation; Quality of Life; Cost Effectiveness; Prediction Model; Communication Aids for Disabled; Prehabilitation; Physical Symptom Distress; Motor Function; Artifical Intelligence; Case Management, APP(Application)

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)

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

Secondary Outcomes (5)

• Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire

  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

  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

  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

  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

  3 months after surgery, and 6 months after surgery

Study Arms (2)

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.

Behavioral: Conventional physiotherapy; Behavioral: Scar management

Intervention group

EXPERIMENTAL

The patients in this group will receive and use AI APP while receiving usual care.

Device: Prehabilitation application; Behavioral: Scar management; Behavioral: AI-based physiotherapy

Interventions

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.

Intervention group

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

Control group Usual care

Scar management BEHAVIORAL

scar massage and jaw-mobilizing exercises combined with devices or depressors

Control group Usual care; Intervention group

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

Intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Risk populations for walking or performing exercise
• Patients with cognitive impairment or psychiatric diseases

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Taiwan University Hospital: collaborator
• National Yang Ming Chiao Tung University Hospital: collaborator

Study Sites (5)

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

ENROLLING BY INVITATION

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Shiow-Ching Shun

CONTACT

+886-911-268-998; scshun@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: May 1, 2026
• Study Start: September 27, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)