2012-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/648275摘要：肺癌是最具侵襲性及威脅生命的癌症之ㄧ，其高死亡率往往造成病人的極大威脅，近年來由於對於健康及健檢的重視，越來越多的民眾在肺癌早期即被診斷出來，台灣地區以非小細胞肺癌為主，早期之治療以手術切除為主，雖然早期肺癌病人 (指stage I 及 II) 的存活時間已相對高於侵襲性肺癌，然其五年存活率仍僅約50%，多數病人可能處於擔心害怕癌症復發 (Fear of Recurrence)，另外，由於手術切除治療，是否亦造成病人的身體功能之改變，該群病人的體能及生活品質是否受影響，相關的臨床問題及研究，往往因病人已完成治療 (手術) 而被忽略，另外，早期肺癌病人的生理與心理壓力及生活品質之衝擊，以及病人對於克服癌症的正向自我效能，與病人癌症復發是否有相關？過去之研究十分有限，並且些對於許多癌症病人「害怕復發」的評估及中文評估量表亦不足。為提供及時與更高品質的癌症護理，以及建置未來發展該方面實證為基礎的介入性照護措施，本三年期研究分為二大階段，第一階段（為期八個月）為量表發展測試研究，目的在為翻譯與測試「害怕癌症復發量表」中文版，針對接受過手術，術後三個月之早期肺癌病人，以翻譯後具內容效度之量表對20-25 位符案之病人，進行量表之適當性及病人表面效度測試，確定量表可行後，進一步則針對至少210 位同樣條件之早期肺癌病人，進行信度與效度檢測,包括內在一致度與再測信度，以及建構效度。第二階段 (第1 年的後4 個月至第2 與第3 年)為前瞻性縱貫性研究，針對早期肺癌術後病人，由術後三個月開始，追蹤病人二年，目的在於 (1) 探討二年間病人在生理與心理狀態的變化 (包括生理方面: 疲倦、呼吸困難、疼痛、肺功能狀態與慣用手肌力；心理方面: 害怕復發嚴重程度、憂鬱、自我效能)；(2) 探討二年間病人在整體生活品質及五大生活品質相關領域(生理、心理、角色、社會支持及認知) 的變化；(3) 探討在控制癌症期別後，早期肺癌病人在術後二年內復發時間 (復發由醫師根據病人臨床症狀及理學檢查後，發現肺癌有局部復發或遠處轉移者；復發時間指由手術後開始到復發當月的總月數) 與以上所測的變項改變之相關性，包括術前肺功能、術後三個月時之肺功能、整體生活品質分數變化、生理功能之變化 (慣用手握力、Karnofsky 生活功能、疲倦、呼吸困難程度及疼痛)、心理狀況之變化 (害怕癌症復發嚴重程度、憂鬱與自我效能之變化)；(4) 針對研究目的(3)中有顯著意義之相關因素變項，分為有復發與沒有復發病人兩組，比較有顯著意義的這些因素在兩組病人間的變化之不同。第二階段符案之條件為新診斷為早期肺癌且接受手術之病人，其將接受總共5 個時間點之評估訪談，手術後三個月(T1)、手術後六個月(T2)、手術後一年(T3)、手術後18 個月 (T4)，手術後兩年 (T5)，手術前之肺功能測試以及病人之癌症期數，則視為重要之單一變相處理 (不評估其五個時間點之變化)；第二階段主要以描述性統計分析各項變相之平均值及其變化，以General EstimatingEquation (GEE) 在控制癌症期別後，以上因素對於病人二年間復發與否之預測力。此階段初步根據GEE 模式，分析所需之個案數，預估為107 人，預期本研究將可深入暸解台灣早期肺癌病人，在癌症診斷衝擊及手術治療後二年間生心理及生活品質之變化，作為臨床實務之依據，以協助病人有較好之生活品質，並且初步探討除了癌症期別外，相關於早期病人之復發因素。<br> Abstract: With the high mortality rate, lung cancer is one of the most invasive cancers.Since the improvement of health examination, more lung cancer patients have beendiagnosed in their early stages, so called early stage lung cancer (Stage I & II).However, to patients with early stage lung cancers, “fear of recurrence” has been themajor concern which may influence patients’ physical, psychological and quality oflife. In the past, lack of attention has been on these early stage lung cancer patientsdue to the busy OPD. Thus, little information has known about patients’multi-focused concerns, particularly, about “fear of cancer recurrence” and how thesedistress are related to patients’ cancer recurrence.This three-year study has two phases, including the first phase (the first 8 monthsof this study) and second phase (from the 9th month in the first year to the rest of2years). In first phase, we aim to “translate and validate the Fear of CancerRecurrence Inventory” (FCRI) in to Chinese version in at least 210 early stage lungcancer patients who have at least 3 months after lung cancer surgery. We willexamine its reliability, factor structure, and construct validity. In second phase, wewill follow patients from 3, 6, 12, 18 & 24 months after surgery (T1-T5, respective)and aim to (1) assess the changes of those major physical factors (fatigue, dyspnea,pain and dominant hand muscle power, and Karnofsky performance level) andpsychological factors (depression, fear of recurrence and self-efficacy on coping withcancer); (2) assess the changes of the overall QOL and the changes of 5 QOL relatedfunctions (physical, emotional, cognitive, role and social support) by EORTCQLQ-30; (3) After control for cancer stages (stage I & stage II), to identify factorsfrom a set of independent variables (including pre-surgery lung function and lungfunction 3 months post-surgery, and changes of fatigue, dyspnea, pain and dominanthand muscle power, and Karnofsky performance level, depression, fear of recurrenceand self-efficacy on coping with cancer, and overall score changes of QOL) to predictthe months of recurrence using months since surgery to recurrence. Finally, if factorssignificantly identified from the research purpose 3, then we will describe and analyzethe changes of the or these factor(s) between patients with recurrence ornon-recurrence.We expect the results of this study can provide evidence-based information aboutearly stage lung cancer patients of their changes in important disease experience.Factors identified from this study about predicting patients’ recurrence, will also helpclinicians to better provide timely and appropriate intervention to these patients toenhance their life quality.