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

Обзор

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.

Вмешательства

• Поведенческое PERMA-H model mobile-based rehabilitation support program
  The DDA comprised seven functional modules-Awakening Mind (P), Flow Experience (E), Supportive Connection (R), Meaning Reconstruction (M), Achievement Motivation (A), Self-Management (H), and Helpline. Each module corresponded to a specific element in each intervention design.The intervention commenced during the week of decannulation. An initial one-on-one, face-to-face session was conducted in hospital to introduce the DDA platform and explain key precautions. The remaining six sessions were c

Первичные конечные точки

• Hope [Срок оценки: 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]

Вторичные конечные точки (6)

• perceived social support [Срок оценки: 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]
• self-efficacy [Срок оценки: 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]
• rehabilitation willingness [Срок оценки: 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]
• Swallowing function assessment [Срок оценки: 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]
• Speech intelligibility assessment [Срок оценки: 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]
• the number of rehabilitation sessions [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Hainan Medical University — Haikou

Малайзия · 1 центр

• The Affiliated Hospital of University of Malaya — Kuala Lumpur

Идентификаторы

NCT: NCT07714967 · HYMLL-2026-280

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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