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
Qualifiers
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
Treatments tested in this trial
- PERMA-H model mobile-based rehabilitation support program
Treatment groups
Sponsors and collaborators
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