2017-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/704160摘要：背景 基因研究的突破，造成近年來抗癌標靶藥物的蓬勃發展，已經成為抗癌治療的新趨勢之一，其大大提高癌症病人存活，其中酪胺酸脢抑制劑 (tyrosinekinaseinhibitor (TKI) 類口服標靶藥物的使用，如慢性骨髓性白血病 (CML) 及胃腸道基質瘤(GIST) 病人，共同皆使會用的第一線TKI 藥物Glevic (Imatinib)，成功地提升五年以上，甚至終身存活的可能性。但是，長期或終身服用標靶藥，亦可能帶來副作用，造成病人身心苦痛 (physical & psychological distress)，認知與生活功能的改變，病人服藥遵從性如何，以及新診斷病人在此過程中的照護需求為何，及受那些因素影響，該方面研究有限。因此，本研究整體的目的在於探討該二群皆會使用一樣的第一線藥或類似之藥物，需長期甚至終身服藥CML 及GIST 病人，服用標靶藥物的苦痛、服藥遵從性、照護需求及後二者之相關因素。研究目的及方法 本研究為期三年分兩個階段，第一階段為研究之第一年，採橫斷性研究，主要目的為：(1) 探討現況中CML 及GIST 病人服用標靶藥物時身體及心理苦痛(distress)、對藥物的遵從性與照護需求；(2) 以二個迴歸模式，分別探討影響標靶服藥遵從性(模式一)，以及照護需求 (模式二) 的因素。第二階段縱貫性研究，針對初使用標靶藥物之CML 與GIST 病人(通常亦為新診斷之病人)“服藥適應的第一年”，連續追蹤十二個月共六次 (標靶藥物治療前、治療後第一、二、三、六及十二個月)，目的：(1) 探討服藥期間身心的苦痛、藥物遵從性和照護需求的改變；(2) 以二個廣義估計方程式 (GEE)，分別探討可能之相關自變項的變化 (重要人口學特質、身心理苦痛的嚴重程度、認知與生活功能、社會支持、診斷別、標靶用藥相關變項) 與服藥遵從性及照護需求變化之關係。第二階段，鑒於本研究二類診斷之病人數相對較少，且需長期追蹤，此階段研究將由第一年第六個月開始，且於北部及中部各增一個收案點，共三個收案點，IRB 通過後，不同點之收案助理將統一訓練，以確保收案之一致性與資料品質。研究工具及分析 本研究兩階段皆探討CML 及GIST 病人之 (1)症狀嚴重度、(2)憂鬱與擔心復發嚴重程度、(3)認知與生活功能、(4) (5)服用藥物的遵從性、(6)照護需求、(6)疾病和基本資料。依據上述之探討變項，採用以下研究工具測量: (1)症狀嚴重度量表；(2) 醫院焦慮憂鬱量表-憂鬱子量表，和害怕癌症復發量表( FCRI)；(3) 世衛組織失能評估表-認知與生活功能子量表(WHODAS-cognition &Living Activities)；(4) 用藥遵從度量表(MAS)；(5)支持性照護需要調查 (SCNS-34& SCNS- 9, 依序分開用於第一及第二階段)；(6) 社會支持量表 (MOS-SSS)¸與(7) 病人背景及疾病治療資料表 (BDTIF)。第一階段將主要採用描述性統計與迴歸分析，第二階段則以描述性統計及廣義估計方程式為主。本研究依統計方法估算樣本數，預計第一階段將收200 位病人，第二階段收130 位病人。預期結果及成果 口服標靶治療為癌症治療之最新趨勢，對病人經驗之研究很有限，本研究藉長期或終身服用TKI 標靶治療之CML 及GIST 病人，探討其對於癌症病人可能造成之苦痛，以及長期服藥及照護需求現況與初使用該類藥物之變化，將做為未來建構出更接近病人需求及增加服藥遵從性的照護模式之根據。<br> Abstract: Background & Overall Purpose The advent of the targeted therapy, such asimatinib (tyrosine-kinase inhibitor/TKI), has dramatically increased the 5 yearsurvival time in patients with CML and Gastrointestinal Stromal Tumor (GIST).However, long-term or life-long oral targeted therapy might also increase patients’distress, influencing patients’ cognitive and life activity function, medicationadherence and related care needs. However, very limited information has been knownabout patients’ experiences. The overall purpose of this study is to examine thedistress, medication adherence and care needs in this 2 cancer populations receivingTargeted therapy.Specific Aims &Methods This is a two-phase study. Phase I is a cross-sectionalsurvey study with the specific aim as: (1) examine physical and psychological distress,selected functional status (cognition and daily activities), adherence in medicationtaking and unmet care needs in patients with CML and GIST who are receivingtargeted therapy; and (2) Identify factors related to patients’ adherence and unmet careneeds with two regression models (adherence & unmet care needs as 2 dependentvariables/models, respectively). The second phase is a 1-year follow-up prospectivelongitudinal study. We attempt to examine patients newly taking targeted therapy oftheir adjustment process. Patients will be assessed before taking the first targetedtherapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively). The specific aimsare to (1) examine the changes of perceived physical and psychological distress,selected functional status, social supports, medication adherences and unmet careneeds; and (2) identify factors (selected demographic factors, distress, selectedfunction status, types of diagnosis and variables associated to targeted therapy)related to patients’ medication adherence and unmet care needs by two GEE models(one for adherence and one for unmet care needs, respectively). Concerning therelatively few cases in both diagnostic population, the data collection will be startedfrom the 6th months of the first year with additional 2 data collection sites. After theapproval of IRB, research assistants in different data collection sites will be trainedfor maintaining the consistency and quality of data collection.Measures & Statistics For both phases, patients will be assessed of their (1)symptom severity (measured by SSS), (2) psychological distress (measured byHADS-Depression & FCRI severity subscale), (3) cognitive and life activity function(by WHODAS), (4) adherence (by MAS) , (5) social support (by MOS-SSS), (6)unmet care needs (by SCNS-34 & SCNS-9 for Phase I & Phase II, respectively), and(7) Background and disease–treatment information (by BDTIF). For Phase I, data willbe analyzed primarily by descriptive statistics and two regression models (one formedication adherence, and one for care needs). For Phase II, data will be analyzed primarily by descriptive and GEE. Based on sample power analysis, we estimate torecruit 200 patients in phase I; and recruit 130 patients in phase II.Expected Outcomes and Future Implications Although CML and GIST are not themost prevalent cancers in Taiwan, we aim to use both group of patients groups toexamine the current status and changes of distress, adherences and care needs inpatients are taking long-term or life-long TKI derived oral targeted therapy. FromPhase II study, the changes of newly TKI targeted therapy takers’ distress, adherencesand care needs would be carefully and in depth examined. It will provide health careprofessionals a more comprehensive picture about the changes of patients’ distress,adherence and care needs during taking oral targeted therapy. The results will alsoprovide as a basis and evidences for better development a timing and comprehensivecare models to fit and increase patients’ life quality during receiving the mostadvanced targeted therapy.