NCT07714967Toborzás még nem indult

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 20.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toborzás még nem indult
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 100 (tervezett)
Első benyújtás: 2026. jún. 30.
Kezdés: 2026. aug. 1.
Elsődleges befejezés: 2026. nov. 1.
Fő szponzor: Hainan Medical College
Betegségek: Fej-nyaki daganatok
NCT-szám: NCT07714967

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 100
2026. aug. 1. és az elsődleges befejezés (2026. nov. 1.) között
2 helyszín, 2 országban
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Korábbi kezelés

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

Más betegség

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

Egyéb

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

Kiket keres a vizsgálat

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

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (2)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
The Second Affiliated Hospital of Hainan Medical University Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Haikou	Kína	Ismeretlen állapot
The Affiliated Hospital of University of Malaya Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Kuala Lumpur	Malajzia	Ismeretlen állapot

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