摘要:研究計畫名稱:身心靈夫妻支持團體於乳癌存活者與其配偶之療效-第三階段臨床試驗背景. 乳癌存活率的增加使得存活者和其伴侶經歷在回到正常生活過程中,面臨過渡時期的挑戰。過去研究已報告關於存活者和其伴侶之間於憂鬱和生活品質的相互關係,親密關係是存活者和其伴侶能對癌症有良好適應的重要因子。但目前研究對於團體治療減輕存活者和其伴侶困擾和改善他們親密關係的成效,以及神經內分泌於產生效果所扮演的治療機轉尚未有完整的探討。我們的前驅試驗結果發現身心靈夫妻支持團體可能對存活者和其伴侶於緩解憂鬱症狀和負面的壓力身心反應有保護的效果。但由於前驅試驗採用非隨機試驗設計而無法有效說明身心靈夫妻支持團體的療效,因此本研究為第三階段臨床試驗採隨機控制設計以克服設計限制並能以嚴謹方式說明此身心靈夫妻支持團體的療效。目的. 本研究目的:(1)探討身心靈夫妻支持團體對乳癌存活者及其伴侶的婚姻親密關係、睡眠品質、生命意義、憂鬱、焦慮、生活品質、唾液可體松的效果,(2)探討乳癌存活者及其伴侶之間於上述效果的相互關係。研究方法. 本研究設計為一隨機控制之臨床實驗(the randomized controlled trial, RCT)。本研究將邀請醫院外科門診的轉移性乳癌存活者參與本研究,他們的伴侶將經由存活者的邀請參加。預期120 位存活者和其伴侶將經由隨機選擇的方式分別至兩個組別:控制組的乳癌存活者及其伴侶僅接受例行性照護,實驗組的乳癌存活者及其伴侶接受的八週身心靈夫妻支持團體介入措施。測量工具包括親密關係經驗量表、Moss 睡眠量表、生命意義問卷、貝氏憂鬱量表第二版,STAI 焦慮量表,SF-12 生活品質問卷,以及唾液可體松的濃度和晝夜型態(the diurnal cortisol patterns)。測試時間將於治療前、治療後(八週身心靈夫妻支持團體後)以及治療後第三個月、六個月和十二個月進行。Univariateanalyses 將分析個案之基本特性. Generalized estimating equation (GEE) models 測試研究假設:(1) 婚姻親密關係、睡眠品質、生命意義、憂鬱、焦慮、生活品質、唾液可體松的效果,實驗組高於控制組的乳癌存活者及其伴侶;(2)癌存活者及其伴侶之間於上述效果有正向的相互關係。預期貢獻:研究計劃的預期貢獻是說明身心靈夫妻支持團體介入於乳癌存活者及其伴侶的成效以及發展適用於臨床的照護手冊。
Abstract: The title of the research project: The efficacy of body-mind-spirit couple support group forbreast cancer survivors and partners-the III stage of clinical trialBackground. The increasing survival rates of breast cancer leads the survivors and theirpartners to face the challenge of negotiating the transition to normal life. Theinterrelationships between survivors and partners in depression and quality of life have beenrecently reported in the research studies. The close marital relationship is the key forsurvivors and partners to have a good adaptation to cancer. However, the efficacy of coupletherapy for both survivors and partners and the mechanisms of neuroendocrine functionbehind the effects are not well-studied. In our pilot study, the results suggest thatbody-mind-spirit (BMS) couple support group might provide protective effects for breastcancer survivors’and their partners’resistance to abnormal depression and negativepsychophysiological responses to stress. However, the non-randomized design used in thepilot study limits in demonstrating the efficacy of BMS couple support group. Therefore, thisIII stage of clinical trial will adopt the randomized controlled trial (RCT) to mitigate thislimitation.Aims and objectives. This study aims (1) to examine the effects of the body-mind-spiritcouple support group on marital close relationships, sleeping quality, depression, anxiety,quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancersurvivors and partners, (2) to examine the interrelationship between survivors and partners inthese effects.Methods. The design adopts the randomized controlled trial (RCT). The metastatic breastcancer survivors will be recruited from outpatient department of surgical at hospital. Thepartners will be invited to participate in this study through the survivors. The 120 dyadsurvivors and spouse will be randomly assigned into an experimental group or a control group.Survivors and spouse partners in an experimental group will receive 2 months timebody-mind-spirit couple support group while those in a control will receive usual care in thesame period of time. The outcome measures include Experiences in close relationships scale,Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning oflife questionnaire, BDI-II depression scale, State-Trait Anxiety Inventory (STAI) and salivarycortisol levels and the diurnal cortisol patterns. Measurement time-points include preintervention, post intervention (after 8 weekly body-mind-spirit couple support group), & then3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyseswill be performed to explore the basic characteristics of participants. The generalizedestimating equation (GEE) model will be used to test the hypothesis (1) the improvement ishigher in intervention group than the control group in the effects of marital close relationships,sleeping quality, depression, anxiety, meaning of life, quality of life, and salivary cortisollevels in metastatic breast cancer survivors and partners, (2) there is the positiveinterrelationship between survivors and partners in these effects.The contribution. The project aims to demonstrate the effectiveness of body-mind-spiritcouple support group for survivors and spouse partners during survivorship and to compile amanual of body-mind-spirit couple support group for health professional.