Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decanulation | — | UNRESOLVED | — |
| Hope | — | UNRESOLVED | — |
| Mental Health | — | UNRESOLVED | — |
| Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Perceived Social Support | — | UNRESOLVED | — |
| Rehabilitation Outcome | — | UNRESOLVED | — |
| Self Efficacy | — | UNRESOLVED | — |
| Speech Intelligibility | — | UNRESOLVED | — |
| Swallowing Function | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PERMA-H model mobile-based rehabilitation support program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PERMA-H model mobile-based rehabilitation support program
- interventionNames
- Behavioral: PERMA-H model mobile-based rehabilitation support program
- type
- NO_INTERVENTION
- label
- routine nursing care
Primary outcomes (1)
- measure
- 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
- description
- The Herth Hope Index is widely used in clinical research to assess hope levels among adult patients. The instrument shows good reliability, with a Cronbach's α of 0.85. Developed by Herth (1992) as a shortened version of the original 30-item Hope Scale, it was translated and culturally adapted for China by Zhao (1997), resulting in a three-dimensional structure: positive attitude toward reality and the future (4 items), taking positive actions (4 items), and maintaining close relationships with others (4 items). Each item is rated on a 4-point Likert scale, ranging from 1 ("strongly disagree") to 4 ("strongly agree"), with Items 3 and 6 reverse-scored. The total score ranges from 12 to 48, with higher scores reflecting greater levels of hope. Specifically, scores of 12-23 indicate low hope, 24-35 indicate moderate hope, and 36-48 indicate high hope.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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-based rehabilitation support program * Unexpected inability to complete the full intervention cycle, including planned hospital transfer or prolonged loss to follow-up * Concurrent participation in other clinical studies primarily focused on psychological or mobile health interventions that could confound study outcomes
References
Publications (0)
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