2015-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/703857摘要：文獻指出預防性癌症復健可以降低治療中的死亡率、再住院率及降低因癌症而引 起的直接或間接費用，亦可增進身、心理層面之健康；因此預防性癌症復健照護，應 該在症狀出現前就開始介入，預防可能即將發生的問題。胰臟癌病患常在經歷手術後 出現嚴重的疲倦、症狀困擾以及營養問題。然而，目前臨床上並未有任何預防性復健 照護概念之介入，以改善胰臟癌術後的疲倦與營養問題。因此，此三年期計畫之研究 目的：（1)瞭解可開刀之胰臟癌病患從術前到術後之疲倦以及營養狀況改變及其照護需 求。（2)依據（1)之研究結果發展術前至出院後3個月相關於疲倦與營養之預防性復健 照護内容，並測試此照護内容於改善疲倦、營養問題與生活品質之成效。第一階段(第1年）採量性合併質性之縱貫式研究設計，選取預計開刀之胰臟癌病 患於手術前、後，以及出院後訪談，以瞭解其於治療前、後相關疲倦與營養問題、生活 品質以及照護需求之改變。量性部分使用症狀嚴重量表、疲倦症狀量表、營養評估、手 部握力及Short form-12生活品質量表評估病患之症狀嚴重度、疲倦、營養以及生活品質 程度，資料收集共6次(手術前、手術後第1,2,3,6, 12個月）。使用描述性統計、Pearson’s 相關性分析、廣義線性推估模式(generalized estimating equations; GEE)，以瞭解症狀嚴重 度與疲倦、營養以及生活品質，並分析生活品質之重要預測因子。質性部分，旨在探討 未滿足需求照護之問題與改變情形，採半結構問卷之4次(手術前、手術後第1,2,3月） 深度質性訪談，全程錄音逐字抄錄後，以内容分析進行資料整理分析，並依據此階段結 果發展預防性復健照護衛教手冊。預估第一年完成量性問卷54位以及質性訪談至少15 位。第二階段(第2-3年）主要為發展與測試預防性復健照護於改善疲倦與營養及整體生活品質之成效，採分層臨床隨機試驗，於台北市某一醫學中心一般外科門診，選取預計進行手術之新診斷胰臟癌病患為研究對象，依據手術術式(胰臟全部切除或部分切除） 分層後，隨機分配至對照組或實驗組。對照組接受目前的常規照護及6次一般探視，而 實驗組接受6次包含術前及術後第2、4、6、8、12週疲倦與營養處理之衛教與個別化 運動建議。將以疲倦、手部握力、營養評估（迷你營養評估及身體組成分析）與生活品質 為介入措施後之主要監測指標，術後一年存活率為次要結果。使用症狀嚴重量表、疲倦 症狀量表、營養評估、手部握力及Short form-12生活品質量表評估病患之症狀嚴重、疲 倦、營養以及生活品質；結果測量時間共計6次，分別於手術前、術後第1,2,3, 6,12個 月。資料將以描述性統計、獨立t檢定以及廣義線性推估模式(generalized estimating equations; GEE)進行分析，以瞭解個人化預防性復健照護於改善疲倦、營養、生活品質 之成效。以存活分析探討二組在術後一年存活率是否有差異。此階段實驗組與對照組各 57人，考量流失率28%，預計此階段共需徵求114位病患。預期結果：預期本研究結果可瞭解術前及術後早期預防性疲倦與營養之復健照護 於改善疲倦、營養、生活品質之成效，同時發展適合台灣胰臟癌之預防性復健照護指引， 並作為未來促進臨床照護品質之參考。<br> Abstract: The evidences have shown that cancer prehabilitation can decrease the mortality during treatment, readmission rate and the cost direct and indirect related to treatment and improve physical and psychological related quality of life. Therefore, cancer prehabilitation can prevent the problems through early taking care of them before it becomes severe status. Patients with pancreatic cancer after receiving operation procedure always experience severe symptoms with fatigue, physical distress, and malnutrition. However, there is no cancer prehabilitation program for them in current clinical settings. Therefore, the aims of this three-year study are to (1) explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months; and (2) develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.In the first phase (the 1st year), the longitudinal design with qualitative and quantitative methods will be conducted to recruit eligible subjects from outpatients on a medical center in Taipei. The eligible subjects will be patients with patients newly diagnosed as operable pancreatic cancer and waiting for the surgery procedure. Quantitative data collection will be on baseline before intervention (T0), in 1(T1),2 (T2),3(T3),6 (T4),12 (T5 ) months after surgery to explore the change of fatigue, nutritional status and care needs. A set of questionnaire with the Symptom Severity Scale, Fatigue Symptom Inventory, Mini Nutritional Assessment, and short form -12 will be used to assess the change of symptom distress, fatigue, nutritional status, and QOL. The muscle strength and body composition analysis will be used to examine hand grip and nutritional status. Data will be analyzed by descriptive, Pearson’s correlations, and generalized estimating equations to examine the change of measured concepts and identify the significant factors affecting QOL. The semi-structured interview guide with digital record will be used to collect the quality information with the change of unmet needs from T0 toT3. Content analysis will be used to analyze the information. Totally, 54 patients will be approached in quantitative approach and at least 15 patients for the in-depth interview. The patient-centered cancer prehabilitation care program will be developed based on the results in this phase.In the second phase (the 2nd-3rd year), developing and testing patient-centered cancer prehabilitation care program, stratified randomization control trial will be used to recruit eligible subjects from outpatients on a medical center in Taipei. The eligible subjects will be patients with pancreatic cancer and are going to receive surgery. They will be stratified by operation procedure and randomized into a control or experimental group. The patients in the control group will receive usual care and 6 usual visiting and those in the experimental group will receive usual care and 6 education programs with physical enhancement and nutrition related information before surgery, at 2, 4, 6, 8, 12 weeks after surgery. Physical symptom, fatigue, muscle strength, nutritional assessment, and quality of life will be primary outcome measurements and 1-year survival rate will be the second endpoint. Six time points of data collection will be on baseline before intervention (T0), at 1 (T1), 2(T2), 3 (T3), 6 (T4), and 12 (T5) months after surgery. Data will be analyzed by descriptive, student t test and generalized estimating equations to examine the effect of intervention program on fatigue, nutritional status, and QOL. Survival analysis will be conducted to examine if the program affect the 1-year survival rate. Totally, 114 subjects will be approached in terms of including a 28% dropout rate in this phase.We expect this study to develop and validate the effects of patient-centered cancer prehabilitation care program on fatigue, nutritional status, and QOL in patients with pancreatic cancer. We also hope to develop the clinical cancer prehabilitation care guideline in clinical settings to improve the cancer care quality for this population.胰臟癌疲倦營養生活品質Pancreatic CancerFatigueNutritionQuality of Life