2020-08-012024-05-16https://scholars.lib.ntu.edu.tw/handle/123456789/669500摘要：背景：非肌肉層侵犯性膀胱癌是膀胱癌最常見的類型，病人在接受膀胱腫瘤刮除術第一年間，每三個月接受膀胱鏡檢及3-6次膀胱化療灌注，目前對頻繁的檢查和治療所產生的擔心復發和疾病衝擊缺乏相關研究。目的：本研究分二階段，第一階段發展中文版「歐洲癌症研究與治療組織－非肌肉層侵犯性膀胱癌生活品質量表」，檢視病人生心理困擾和生活品質；第二階段為隨機分派臨床試驗，發展多面向積極生活模式佐以電子輔助介入措施，與控制組比較成效。方法：第一階段發展並確立中文版生活品質量表信效度，檢視病人的症狀、害怕復發、性與親密關係、身體功能現況，預計收案240人；第二階段發展多面向積極生活模式介入措施，內容包含生心理困擾處置及協助積極面對生活，實驗組同時有腫瘤個案管理師照護及接受4次MAP介入：出院前、術後第1次門診、第3及6個月，介入前將透過APP發送建議，病人亦可透過APP提出問題，預計進行5次成效評估：每次介入前及術後12個月，控制組接受常規照護，同樣接受5次量表評估，預計兩組各收錄60人，共120人，資料將以GEE進行分析。預期結果：本研究為第一個建立中文版膀胱癌生活品質量表，並發展多面向積極生活模式的研究，將有助於臨床系統性照護指引的建立。<br> Abstract: Background: Non-muscle invasive bladder cancer (NMIBC) covers the majority of bladder cancer incidence. Operable NMIBC patients have to receive Transurethral Resection of Bladder Tumor (TURBT), every-three-month repeated cystoscopes and bladder-irrigated chemotherapy in the first year. The intrusion, repeated cystoscope/treatments and recurrence concern may influence NMIBC patients’ quality of life. Purposes: This is a 2-phase study. The aim of Phase I (first year) is to (1) test the psychometrics of NMIBC–specific Quality of Life (QOL) questionnaire “EORTC QLQ NMIBC 24-Chinese”; (2) examine patients’ distress across multi-domains, including impacts on QOL, symptoms, physical function (upper/lower leg muscle power, balance), sexual/intimacy, fear of recurrence, and physical activity. Phase II (2nd&3rd year) is a two-group randomized trial for newly diagnosed NMIBC patients. It aims to (1) construct a Multi-domains Active-living Program (MAP) with e-health enhanced intervention; and (2) compare the effects of the MAP with oncology case manager (OCM) care (experimental group) and OCM care only (control group) of the effects on the above indicators (phase I) and the number of unexpected hospital visits. Methods: Phase I is an instrument validation study. The “EORTC QLQ-NMIBC24-Chinese” will be to develop and examine of its psychometrics. We will also explore the above mentioned domains of QOL, distress, care needs, frequency of taking physical activities, etc. by questionnaire interview/assessment; and objective physical function measures (low leg muscle strengths and balance ability). An estimated sample size is 240 subjects. Phase II is a 12-month two-group randomized trial, including OCM care only (control), Vs. MAP+OCM program (experimental group). MAP will be constructed based on literature review and preliminary results. Main contents of MAP are to (a) cope multi-domain of distress, and (b) develop an active life style to handle their life after cancer, including effective coping, relaxation, regular physical activities, and balance nutrition. Four face-to face interventions will be delivered, including: day before hospital discharge post-operation, the first post-op OPD visit, 3- and 6- month post operation (section 1-4), respectively. A brief and automatic app reminder (before) and side-effect follow-up (after) from 2nd section of face-to face intervention will be sent. Boosting app supports will be also sent in 9th and 12th months before final assessments. Patients in the MAP+OCM group also can raise their questions through APP to receive brief intervention. The outcomes will be assessed at 5 time points: time before first intervention, before 2nd to 4th interventions, and 12 months, T1-T5, respectively. We will use Generalized Estimated Equation (GEE) to analyze the data with total 120 subjects (60 Vs 60 estimated). Expected Outcome: This is the first study to test EORTC QLQ-NMIBC24 Chinese version, patients’ distress and physical function as well as construct and test of a multi-domain MAP program. It would help us further build up evidence-based care and generalize to bladder cancer patients.非肌肉層侵犯性膀胱癌生活品質疾病衝擊健康促進積極生活介入措施害怕復發Non-muscle invasive bladder cancerQuality of LifeDisease impactHealth promotionActive livingInterventionFear of recurrence