Not Yet RecruitingNot Applicable

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

China, Malaysia100 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 * 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-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hope

Timeframe: baseline (T0), "From enrollment to the end of intervention at 4 weeks", immediately post-intervention (T1), and at one-month (T2) and three-month (T3) follow-ups

Trial details

NCT IDNCT07714967

SponsorHainan Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Mingxiang Li, Master

+8618389291371 1364044138@qq.com

View on ClinicalTrials.gov More Tracheostomized Patients trials