[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660021":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":57,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":100,"collaborators":104,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":43,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":43,"enrollmentInfo":115,"targetDuration":43,"studyType":118,"phases":119,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":129,"whyStopped":43,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":43},[9,13,16,19,22,25,29],{"measure":10,"description":11,"timeFrame":12},"Feasibility outcome: time to complete the recruitment","Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.","Through recruitment completion, up to 3 months",{"measure":14,"description":15,"timeFrame":12},"Feasibility outcome: eligibility rate","Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.",{"measure":17,"description":18,"timeFrame":12},"Feasibility outcome: recruitment rate","Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been enrolled by the total number of eligible participants.",{"measure":20,"description":21,"timeFrame":12},"Feasibility outcome: retention rate","Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants enrolled at the baseline.",{"measure":23,"description":24,"timeFrame":12},"Feasibility outcome: attendance rate","Attendance rate will be calculated by dividing the number of participants completed five interventional sessions by the number of participants enrolled at baseline.",{"measure":26,"description":27,"timeFrame":28},"Acceptability outcome: participants' satisfaction and perspectives of the intervention","Participants' perspectives and satisfaction will be assessed using a self-developed questionnaire, designed for this study based on the Theoretical Framework of Acceptability","Post-intervention, up to 3 months",{"measure":30,"description":31,"timeFrame":28},"Qualitative evaluation of acceptability","A qualitative evaluation will explore the acceptability of the digitally-enabled psychological intervention for demoralization in advanced cancer patients. Semi-structured individual interviews will be conducted after participants complete the intervention, using an interview guide focused on their overall experience and perceived usefulness of the sessions. All interviews will be audio-recorded and transcribed verbatim.",[33,37,40],{"measure":34,"description":35,"timeFrame":36},"Demoralization","Advanced cancer patients' demoralization will be assessed using the Demoralization Scale-II (DS-II, Chinese version). This scale consists of 16 items, and each item is rated on a three-point Likert scale (0 = not at all to 2 = to a large extent), yielding a total score range of 0-32. Higher scores indicate greater level of demoralization.","Baseline; Week 5",{"measure":38,"description":39,"timeFrame":36},"Suicidal ideation","Advanced cancer patients' suicidal ideation will be assessed using the Beck Scale for Suicidal Ideation (BSSI, Chinese version). This scale consists of 5 items, and each item is rated on a three-point Likert scale (0 = no such thought, attitude, or behavior to 2 = moderate to strong or frequent), yielding a total score range of 0-10. Higher scores indicate greater level of suicidal ideation.",{"measure":41,"description":42,"timeFrame":36},"Health-related quality of life","Advanced cancer patients' health-related quality of life will be assessed using the the McGill Quality of Life-Revised (MQOL-R, Chinese version). This scale consists of 14 items, and each item is rated on a 11-point Likert scale (0 = very bad to 10 = excellent), yielding a total score range of 0-140. Higher scores indicate greater level of health-related quality of life.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"A digitally-enabled positive psychological intervention for demoralization","EXPERIMENTAL","A five-week digitally-enabled psychological intervention for demoralization provided by a trained registered nurse",[56],"Behavioral: A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":43},"BEHAVIORAL","A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients","The intervention will consist of five 30-45 minute individual digital sessions, delivered weekly over five weeks by a trained registered nurse through a WeChat Mini Program. The five sessions will correspond to the five PERMA dimensions (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment), grounded in Seligman's PERMA framework, the Positive Psychotherapy Clinician Manual, and the positive psychological interventions training course. This intervention is intended to address the core dimensions of demoralization in advanced cancer patients, particularly hopelessness, meaninglessness, and helplessness, and to translate positive psychological skills into everyday self-care and emotional regulation. The WeChat Mini Program will contain videos, interactive activity modules, and session guides to support the five sessions.",[52],[64],{"name":65,"affiliation":66,"role":67},"Xuan Liu","The Seventh Affiliated Hospital of Sun Yat-sen University","STUDY_DIRECTOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":43,"email":73},"Wenbo Dou","CONTACT","(+86) 175 0893 9982","wen-bo.dou@connect.polyu.hk",[75],{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"The Seventh Affiliated Hospital of Sun Yat-Sen University","Shenzhen","Guangdong","518001","China","CN",{"type":83,"coordinates":84},"Point",[85,86],114.0683,22.54554,{"lat":86,"lon":85},[89,91,94,96,98],{"name":65,"role":71,"phone":90,"phoneExt":43,"email":43},"(+86) 135 3338 4708",{"name":92,"role":93,"phone":43,"phoneExt":43,"email":43},"Wenbo Dou, Msc","SUB_INVESTIGATOR",{"name":95,"role":93,"phone":43,"phoneExt":43,"email":43},"Ka Wai Katherine Lam, PhD",{"name":97,"role":93,"phone":43,"phoneExt":43,"email":43},"Lauren Parkinson-Zarb, PhD",{"name":99,"role":93,"phone":43,"phoneExt":43,"email":43},"Janelle Yorke, PhD",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Dr CHENG Huilin","Associate Professor",[105],{"name":66,"class":6},"100660021","a-feasibility-study-of-a-digitally-enabled-psychological-intervention-for-demoralization-in-advanced-cancer-patients-100660021",false,"NCT07872254","A Feasibility Study of a Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients","Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients: a Feasibility Study","Inclusion Criteria:\n\n* adult patients ≥18 years old;\n* has a confirmed diagnosis of stage III, or IV solid organ tumor, with a life expectancy of more than three months as determine by oncologist;\n* receiving undergoing chemotherapy treatment;\n* two of the three demoralization-related questions received positive feedback; The three question as follows: i) I find it hard to see any hope; ii) I find what I am going through to be overwhelming; iii) I feel hard to find my sense of worth;\n* should be able to use applications (e.g., WeChat) on a mobile phone;\n* able to communicate in Putonghua, with voluntary participation in the study;\n* answer \"No\" of the question: \"Do you have any thoughts of hurting yourself in some way?\";\n* co-reside with at least one adult family member.\n\nExclusion Criteria:\n\n* has a diagnosed cognitive impairment or major neurological disorder (e.g., dementia, Alzheimer's disease) that, in the opinion of the treating physician, would preclude the provision of informed consent or meaningful participation;\n* has physician-recorded substance or drug use disorder (e.g., alcohol use disorder), which impacts neuropsychological functioning both directly through neurochemistry and indirectly through non-neurological systems;\n* is participating in other experimental research, such as psychological intervention (for example: cognitive behaviour therapy and meaning therapy), or psychological counseling;\n* the diagnosis is not disclosed to the patients and only the main carer\u002Ffamily is aware.","ALL","18 Years",{"count":116,"type":117},30,"ESTIMATED","INTERVENTIONAL",[45],"Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Approximately 35.8% of cancer patients experience demoralization, with higher rates in terminal stages. If unrecognized or untreated, it can increase physical and mental symptom burden, reduce quality of life, and even lead to suicide. To date, no professional bodies currently recommend treatment guidelines. One meta-analysis suggests that psychological interventions could significantly reduce demoralization; however, the requirement for in-person attendance may create accessibility challenges, potentially reducing the flexibility and acceptability of psychological interventions for cancer patients undergoing chemotherapy or receiving treatment at home.\n\nTo address the identified literature gap, a co-designed digital psychological intervention was developed, and this study will evaluate its feasibility. A convenience sample of 30 advanced cancer patients meeting the inclusion criteria will be recruited from the oncology ward of a hospital in Shenzhen. Participants will receive five 30-45 minute sessions of a co-designed, digitally-enabled positive psychological intervention, delivered weekly over five weeks. A trained researcher will introduce the intervention before discharge and deliver it through a WeChat Mini Program in the patients' homes. The primary outcome will be feasibility (time to complete recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, and acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on demoralization, suicidal ideation, and quality of life of advanced cancer patients at baseline (after collecting demographic information and written consent forms) and post-intervention. A separate researcher will conduct a descriptive qualitative evaluation with 12 participants to explore their experience of the intervention. Qualitative data will be audio-taped, transcribed verbatim, and analyzed using NVivo 14 through thematic analysis. Quantitative data will be entered into SPSS version 29.0. Descriptive statistics will be used to summarize the profiles of participants and outcomes.",[122,34,123],"Advanced Cancer","Psychological Intervention",[125,34,126,127,38,128],"Advanced cancer","Positive psychological intervention","Digital health","Quality of life","NOT_YET_RECRUITING","2026-10-07",{"date":132,"type":133},"2026-10-13","ACTUAL",{"date":135,"type":117},"2026-10-28",{"date":137,"type":117},"2027-01-30",{"name":5,"class":6},1]