Clinical Trial

Effects of a Perma-h Model Mobile-based Rehabilitation Support Program on Hope, Self-efficacy, Perceived Social Support and Rehabilitation Outcomes in Post- Tracheostomy Oral Cancer Patients

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Summary
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.
Trial Details
NCT Number NCT07714967
Lead Sponsor Hainan Medical College
Collaborators: Second Affiliated Hospital of Hainan Medical College, University of Malaya, The First Affiliated Hospital of Hainan Medical University, Hainan People's Hospital
Conditions Tracheostomized Patients, Decanulation, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Rehabilitation Outcome, Mental Health, Hope, Self Efficacy, Perceived Social Support +2 more
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-20