[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perceived-social-support\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perceived-social-support":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100647853","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-100647853",false,"NCT07714967","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","Inclusion Criteria:\n\n* Aged ≥18 years\n* Pathologically diagnosed with oral squamous cell carcinoma and undergoing, or scheduled to undergo, tracheostomy followed by decannulation\n* Fully conscious, with a Glasgow Coma Scale score of 15, and able to successfully complete the Three-Step Command Test, indicating intact comprehension ability\n* Able to communicate effectively through verbal speech or alternative methods, including writing, gestures, electronic device input, or voice-assisted tools\n* Able to use WeChat independently or after brief guidance, without communication barriers\n* Has at least one regular family caregiver; both the patient and caregiver fully understand the study content and voluntarily provide written informed consent\n* Free from severe cardiovascular, cerebrovascular, hepatic, renal, or pulmonary disease\n\nExclusion Criteria:\n\n* Presence of other serious malignancies or extensive tumor metastasis\n* Previous or current diagnosis of severe mental illness, such as schizophrenia or severe bipolar disorder\n* Significant cognitive impairment, severe depressive symptoms, or suicide risk that precludes effective participation in psychological interventions\n* Inability to complete assessments or interventions due to severe hearing, visual, or language impairments\n* Inability to communicate effectively through any available alternative means\n* Lack of access to a smartphone and absence of a designated caregiver\n* Explicit unwillingness or inability to use a mobile-based rehabilitation support program\n* Unexpected inability to complete the full intervention cycle, including planned hospital transfer or prolonged loss to follow-up\n* Concurrent participation in other clinical studies primarily focused on psychological or mobile health interventions that could confound study outcomes","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","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\u002Fstandard 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.\n\nThe main questions it aims to answer are:\n\nDoes the PERMA-H model mobile-based rehabilitation support program improve patients' hope? (primary hypothesis\u002Foutcome measure 1) Does the PERMA-H model mobile-based rehabilitation support program improve patients' self-efficacy, perceived social support, and rehabilitation outcomes? (primary hypothesis\u002Foutcome 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\u002Fusual care (control group) to determine differences in outcomes between groups.\n\nParticipants will be asked to complete the main study tasks, including:\n\nparticipating 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 \u002F 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\u002Fparticipation and functional measures such as swallowing function and speech intelligibility as rated by speech-language pathologists).\n\nExpected 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.",[25,26,27,28,29,30,31,32,33,34],"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",[36,37,38,39],"PERMA-H","chatbot","Digital Rehabilitation Support","MODEL MOBILE","NOT_YET_RECRUITING","2026-07-15",{"date":43,"type":44},"2026-07-20","ACTUAL",{"date":46,"type":19},"2026-08-01",{"date":48,"type":19},"2027-02-01",{"name":50,"class":51},"Hainan Medical College","OTHER",2]