About this trial
The goal of this study (exploratory sequential design; mixed-methods study) is to evaluate whether a PERMA-H model mobile-based rehabilitation support program delivered to post-tracheostomy oral cancer patients can improve psychological and rehabilitation outcomes, compared with a control group receiving usual care/standard support. The study will focus on post-tracheostomy oral squamous cell carcinoma (OSCC) patients (aged ≥18 years) who are undergoing or scheduled to undergo tracheostomy followed by decannulation, and who have adequate communication ability and caregiver support.
The main questions it aims to answer are:
Does the PERMA-H model mobile-based rehabilitation support program improve patients' hope? (primary hypothesis/outcome measure 1) Does the PERMA-H model mobile-based rehabilitation support program improve patients' self-efficacy, perceived social support, and rehabilitation outcomes? (primary hypothesis/outcome measure 2) If there is a comparison group, researchers will compare the PERMA-H model mobile-based rehabilitation support program (intervention group) to a control group receiving standard/usual care (control group) to determine differences in outcomes between groups.
Participants will be asked to complete the main study tasks, including:
participating in qualitative interviews to explore their digital needs, expectations, and experiences regarding psychosocial care (Phase I); using the WeChat mini-program platform that incorporates a PERMA-H evidence-based module set and a chatbot (Decannulationbot / Digital rehabilitation Assistant, DDA) as part of the rehabilitation support program; completing validated assessments at study endpoints to measure hope (Herth Hope Index), self-efficacy (General Self-Efficacy Scale), and perceived social support (Perceived Social Support Scale), as well as rehabilitation-related outcomes (including rehabilitation willingness/participation and functional measures such as swallowing function and speech intelligibility as rated by speech-language pathologists).
Expected outcomes include: comprehensive qualitative findings to inform the content and delivery of digital psychosocial support; a functional mobile intervention platform with evidence-based modules validated through expert appraisal and pilot testing; and statistically significant improvements in hope, self-efficacy, perceived social support, and rehabilitation outcomes in the intervention group compared with the control group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Pathologically diagnosed with oral squamous cell carcinoma and undergoing, or scheduled to undergo, tracheostomy followed by decannulation
Fully conscious, with a Glasgow Coma Scale score of 15, and able to successfully complete the Three-Step Command Test, indicating intact comprehension ability
Able to communicate effectively through verbal speech or alternative methods, including writing, gestures, electronic device input, or voice-assisted tools
Disqualifiers
Presence of other serious malignancies or extensive tumor metastasis
Previous or current diagnosis of severe mental illness, such as schizophrenia or severe bipolar disorder
Significant cognitive impairment, severe depressive symptoms, or suicide risk that precludes effective participation in psychological interventions
Inability to complete assessments or interventions due to severe hearing, visual, or language impairments
Trial design
Parallel
Treatments tested in this trial
PERMA-H model mobile-based rehabilitation support program
BehavioralThe DDA comprised seven functional modules-Awakening Mind (P), Flow Experience (E), Supportive Connection (R), Meaning Reconstruction (M), Achievement Motivation (A), Self-Management (H), and Helpline. Each module corresponded to a specific element in each intervention design.The intervention commenced during the week of decannulation. An initial one-on-one, face-to-face session was conducted in hospital to introduce the DDA platform and explain key precautions. The remaining six sessions were completed by participants independently at home using DDA. On each intervention day, reminder messages were sent via Decannulationbot and WeChat groups. Based on prior evidence, the intervention was delivered over four weeks, with two sessions per week (35 minutes per session), completing one module per session, and a three-day interval between sessions to allow practice and consolidation.
Treatment groups
Trial outcomes
Primary outcomes
Hope
The Herth Hope Index is widely used in clinical research to assess hope levels among adult patients. The instrument shows good reliability, with a Cronbach's α of 0.85. Developed by Herth (1992) as a shortened version of the original 30-item Hope Scale, it was translated and culturally adapted for China by Zhao (1997), resulting in a three-dimensional structure: positive attitude toward reality and the future (4 items), taking positive actions (4 items), and maintaining close relationships with others (4 items). Each item is rated on a 4-point Likert scale, ranging from 1 ("strongly disagree") to 4 ("strongly agree"), with Items 3 and 6 reverse-scored. The total score ranges from 12 to 48, with higher scores reflecting greater levels of hope. Specifically, scores of 12-23 indicate low hope, 24-35 indicate moderate hope, and 36-48 indicate high hope.
Secondary outcomes
perceived social support
The Perceived Social Support Scale measures individuals' subjective perception of social support. Widely used in psychology, medicine, and sociology, it demonstrates strong reliability and validity. Developed by Zimet et al. (1990) and revised by Jiang (2001) for cultural adaptation, the Chinese version replaced the "other support" dimension with "support from leaders, relatives, and colleagues," yielding a Cronbach's α of 0.92. The scale includes three dimensions-family support, friend support, and support from leaders, relatives, and colleagues-each comprising four items. Responses are rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), yielding a total score of 12-84. Scores of 12-36, 37-60, and 61-84 indicate low, moderate, and high PSS, respectively.
self-efficacy
The General Self-Efficacy Scale, developed by Schwarzer and Jerusalem (1995), originally comprised 20 items and was later refined to 10. It has been translated into more than 20 languages for global use. The Chinese version, translated and validated by Wang et al. (2001), measures individuals' confidence in managing challenges. Reported Cronbach's α coefficients for this version range from 0.87 to 0.96, indicating strong reliability and validity. Each item is rated on a 4-point Likert scale ("not at all true," "somewhat true," "mostly true," "completely true"), with scores ranging from 1 to 4. The total score ranges from 10 to 40, with higher scores reflecting stronger perceived self-efficacy. Based on the total score, self-efficacy can be categorized into three levels: scores below 20 indicate low self-efficacy, scores between 20 and 30 indicate moderate self-efficacy, and scores above 30 indicate high self-efficacy.
rehabilitation willingness
The Rehabilitation Willingness Questionnaire, developed by Liu et al. (2011) based on the TPB, assesses stroke patients' willingness to engage in rehabilitation. The instrument shows good reliability, with Cronbach's α = 0.79. It comprises three dimensions: behavioral attitude (3 items), subjective norms (4 items), and perceived behavioral control (5 items). Each item is rated on a 5-point Likert scale, producing total scores of 12-60, where higher scores indicate stronger rehabilitation willingness. Scores are categorized as low (12-27), moderate (28-43), and high (44-60).
Swallowing function assessment
Swallowing function was assessed using the water swallowing test proposed by Toshio Kubota, which provides clear grading criteria and is simple to administer. During the assessment, patients are seated and instructed to drink 30 mL of warm water, while swallowing frequency and the presence of coughing are observed. Swallowing performance is graded as follows: 1 point-swallowing the water in a single attempt; 2 points-swallowing the water in two or more attempts without coughing; 3 points-swallowing the water in a single attempt with coughing; 4 points-swallowing the water in two or more attempts with coughing; and 5 points-unable to swallow all the water with frequent coughing. Scores of 1-2 indicate normal swallowing function, whereas scores of 3-5 indicate dysphagia.
Sponsors and contacts
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Hainan Medical College
Lead sponsor
Second Affiliated Hospital of Hainan Medical College
Collaborator
University of Malaya
Collaborator
The First Affiliated Hospital of Hainan Medical University
Collaborator
Hainan People's Hospital
Collaborator
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