Mobile app rehabilitation support for oral cancer patients after a tracheostomy
Tests a mobile rehabilitation support program in adults with oral cancer after tracheostomy.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Kuala Lumpur, MalaysiaSee the site
Where in Malaysia
- The Affiliated Hospital of University of MalayaKuala Lumpur, MalaysiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hainan Medical College
- Trial code
- NCT07714967
- Record updated
- 20 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Able to use WeChat independently or after brief guidance, without communication barriers; Has at least one regular family caregiver; both the patient and caregiver fully understand the study content and voluntarily provide written informed consent; Free from severe cardiovascular, cerebrovascular, hepatic, renal, or pulmonary disease.
Exclusion: Previous or current diagnosis of severe mental illness, such as schizophrenia or severe bipolar disorder; Concurrent participation in other clinical studies primarily focused on psychological or mobile health interventions that could confound study outcomes; Presence of other serious malignancies or extensive tumor metastasis; 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; Inability to communicate effectively through any available alternative means; Lack of access to a smartphone and absence of a designated caregiver; Explicit unwillingness or inability to use a mobile-based rehabilitation support program; Unexpected inability to complete the full intervention cycle, including planned hospital transfer or prolonged loss to follow-up.