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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Mingxiang Li, Master
  • Numer telefonu: +8618389291371
  • E-mail: 1364044138@qq.com

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PERMA-H model mobile-based rehabilitation support program
Behawioralne: 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.
Brak interwencji: routine nursing care

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Hope
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
perceived social support
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hainan Medical College

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

1 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

30 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 lipca 2026

Pierwszy wysłany (Rzeczywisty)

20 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HYMLL-2026-280

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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