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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHainan Medical College

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

100 Participants
are divided into 2 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