NCT07714967Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Hainan Medical College
- Diseases
- Head and neck cancer
- NCT number
- NCT07714967
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Aug 2026 to the primary completion date, Nov 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The Affiliated Hospital of University of Malaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.