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

NCT07714967 | Not Yet Recruiting DMC

• 1 other identifier: HYMLL-2026-280
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Tracheostomized Patients; Decanulation; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Rehabilitation Outcome; Mental Health; Hope; Self Efficacy; Perceived Social Support; Swallowing Function; Speech Intelligibility

Keywords

PERMA-H; chatbot; Digital Rehabilitation Support; MODEL MOBILE

Outcome Measures

Primary Outcomes (1)

• Hope

  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

Secondary Outcomes (6)

• perceived social support

  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

  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

  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

  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

  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

Study Arms (2)

PERMA-H model mobile-based rehabilitation support program

EXPERIMENTAL

Behavioral: PERMA-H model mobile-based rehabilitation support program

routine nursing care

NO INTERVENTION

Interventions

PERMA-H model mobile-based rehabilitation support program BEHAVIORAL

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.

PERMA-H model mobile-based rehabilitation support program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hainan Medical College: lead
• Second Affiliated Hospital of Hainan Medical College: collaborator
• University of Malaya: collaborator
• The First Affiliated Hospital of Hainan Medical University: collaborator
• Hainan People's Hospital: collaborator

Study Sites (2)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

The Affiliated Hospital of University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Psychological Well-Being; Speech Intelligibility

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Personal Satisfaction; Behavior; Speech; Verbal Behavior; Communication

Central Study Contacts

Mingxiang Li, Master

CONTACT

+8618389291371; 1364044138@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1); MY (1)