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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. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Mingxiang Li, Master
  • Telefonní číslo: +8618389291371
  • E-mail: 1364044138@qq.com

Studijní místa

  • Malajsie
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malajsie
        • The Affiliated Hospital of University of Malaya
        • Kontakt:
  • Čína
    • Hainan
      • Haikou, Hainan, Čína
        • The Second Affiliated Hospital of Hainan Medical University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PERMA-H model mobile-based rehabilitation support program
Behaviorální: 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.
Žádný zásah: routine nursing care

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hope
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
perceived social support
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hainan Medical College

Spolupracovníci

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. listopadu 2026

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

30. června 2026

První předloženo, které splnilo kritéria kontroly kvality

15. července 2026

První zveřejněno (Aktuální)

20. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HYMLL-2026-280

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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