Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

15 luglio 2026 aggiornato da: Li Mingxiang, Hainan Medical College

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Mingxiang Li, Master
  • Numero di telefono: +8618389291371
  • Email: 1364044138@qq.com

Luoghi di studio

  • Cina
    • Hainan
      • Haikou, Hainan, Cina
        • The Second Affiliated Hospital of Hainan Medical University
        • Contatto:
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia
        • The Affiliated Hospital of University of Malaya
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PERMA-H model mobile-based rehabilitation support program
Comportamentale: 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 completed by participants independently at home using DDA. On each intervention day, reminder messages were sent via Decannulationbot and WeChat groups. Based on prior evidence, the intervention was delivered over four weeks, with two sessions per week (35 minutes per session), completing one module per session, and a three-day interval between sessions to allow practice and consolidation.
Nessun intervento: routine nursing care

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hope
Lasso di tempo: 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 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.
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
perceived social support
Lasso di tempo: 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 Perceived Social Support Scale measures individuals' subjective perception of social support. Widely used in psychology, medicine, and sociology, it demonstrates strong reliability and validity. Developed by Zimet et al. (1990) and revised by Jiang (2001) for cultural adaptation, the Chinese version replaced the "other support" dimension with "support from leaders, relatives, and colleagues," yielding a Cronbach's α of 0.92. The scale includes three dimensions-family support, friend support, and support from leaders, relatives, and colleagues-each comprising four items. Responses are rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), yielding a total score of 12-84. Scores of 12-36, 37-60, and 61-84 indicate low, moderate, and high PSS, respectively.
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
Lasso di tempo: 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 General Self-Efficacy Scale, developed by Schwarzer and Jerusalem (1995), originally comprised 20 items and was later refined to 10. It has been translated into more than 20 languages for global use. The Chinese version, translated and validated by Wang et al. (2001), measures individuals' confidence in managing challenges. Reported Cronbach's α coefficients for this version range from 0.87 to 0.96, indicating strong reliability and validity. Each item is rated on a 4-point Likert scale ("not at all true," "somewhat true," "mostly true," "completely true"), with scores ranging from 1 to 4. The total score ranges from 10 to 40, with higher scores reflecting stronger perceived self-efficacy. Based on the total score, self-efficacy can be categorized into three levels: scores below 20 indicate low self-efficacy, scores between 20 and 30 indicate moderate self-efficacy, and scores above 30 indicate high self-efficacy.
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
Lasso di tempo: 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 Rehabilitation Willingness Questionnaire, developed by Liu et al. (2011) based on the TPB, assesses stroke patients' willingness to engage in rehabilitation. The instrument shows good reliability, with Cronbach's α = 0.79. It comprises three dimensions: behavioral attitude (3 items), subjective norms (4 items), and perceived behavioral control (5 items). Each item is rated on a 5-point Likert scale, producing total scores of 12-60, where higher scores indicate stronger rehabilitation willingness. Scores are categorized as low (12-27), moderate (28-43), and high (44-60).
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
Lasso di tempo: 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 was assessed using the water swallowing test proposed by Toshio Kubota, which provides clear grading criteria and is simple to administer. During the assessment, patients are seated and instructed to drink 30 mL of warm water, while swallowing frequency and the presence of coughing are observed. Swallowing performance is graded as follows: 1 point-swallowing the water in a single attempt; 2 points-swallowing the water in two or more attempts without coughing; 3 points-swallowing the water in a single attempt with coughing; 4 points-swallowing the water in two or more attempts with coughing; and 5 points-unable to swallow all the water with frequent coughing. Scores of 1-2 indicate normal swallowing function, whereas scores of 3-5 indicate dysphagia.
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
Lasso di tempo: 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 was assessed using the Hofstetter Speech Intelligibility Test, which evaluates the extent to which a patient's speech can be understood by unfamiliar listeners.The assessment was conducted by trained clinicians during routine clinical evaluation, and the resulting scores were extracted from medical records for analysis. Speech intelligibility (%)

= (Number of words/syllables correctly understood by listeners)/ (Total number of words/ syllables presented). For example, if listeners correctly understand 42 out of 50 words, the speech intelligibility score is 84%, a comprehension level of 90% - 100% indicates that the speech is basically completely understandable, 75% - 89% represents a slight decline, 50% - 74% indicates a moderate decline, 25% - 49% represents a severe decline, and anything below 25% suggests extremely severe impairment in speech comprehension.
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
Lasso di tempo: 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
During the early phase of rehabilitation, increasing session frequency is associated with substantial gains in neuroplasticity and motor function recovery. However, once the cumulative number of sessions approaches approximately 30, therapeutic effects tend to plateau. Although additional sessions may yield modest improvements, marginal benefits diminish, and excessive rehabilitation can lead to fatigue, reduced adherence, and increased financial burden.Accordingly, this study set 30 rehabilitation sessions as the recommended total intervention dose and calculated rehabilitation adherence using the formula: (actual number of completed rehabilitation sessions / 30) × 100%. Based on adherence thresholds commonly applied in pharmacological and rehabilitation research, adherence is categorized as high (≥80% of the prescribed dose, ≥24 sessions), moderate (50%-79%, 15-23 sessions), or low (<50%, ≤14 sessions).
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hainan Medical College

Collaboratori

University of Malaya
Hainan People's Hospital
The First Affiliated Hospital of Hainan Medical University
Second Affiliated Hospital of Hainan Medical College

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HYMLL-2026-280

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Salute mentale

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Gambia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi