Effectiveness of a modified dignity therapy programme (MDTP) on dignity, depression, spiritual well-being and life satisfaction for patients with lung cancer undergoing chemotherapy: a randomised controlled trial

Ph.D.BackgroundCancer diagnosis and its treatments produce various challenges for patients, not only regarding the physical symptoms and psychological distress, but also a prominent issue of loss of dignity. Dignity therapy is a promising intervention that utilises reminiscence to enhance dignity for patients with terminal cancer.AimsThis study aims to develop a culturally sensitive psychosocial intervention, namely Modified Dignity Therapy Programme (MDTP) for patients with lung cancer undergoing chemotherapy in mainland China and evaluate its effectiveness on dignity, depression, spiritual well-being and life satisfaction.MethodsBy adopting the Medical Research Council (MRC) framework on the evaluation of complex intervention and guided by the integration of the Erikson’s eighth stage of psychosocial development (EESPD) and the dignity model, this study comprised three phases. Phase I was a systematic review to review the effects of dignity therapy on dignity, depression, spiritual well-being and life satisfaction for patients with cancer. The systematic review also revealed various delivery models of dignity therapy. The results were used to guide the development of an evidence-based protocol. Phase II was a qualitative study (n=20) to explore the perceived dignity by patients with cancer undergoing chemotherapy and identify the factors which support or undermine their sense of dignity. A qualitative descriptive design with face-to-face, semi-structured and individual interviews was adopted. The qualitative study provided implications on the development of the culturally sensitive MDTP relevant to patients in mainland China. Phase III was the main study that adopted a randomised controlled trial (RCT) (N=120) to evaluate the effectiveness of the MDTP. On the basis of Phase I and II, MDTP adopted a family-oriented approach which involved patients and family caregivers in addressing dignity-related distress for patients with lung cancer undergoing chemotherapy. Adult patients (≥18 years old) with lung cancer undergoing chemotherapy were recruited and randomised to receive the MDTP or attention control. Primary outcome included dignity-related distress and secondary outcomes included depression, spiritual well-being and life satisfaction. Generalised estimating equation (GEE) models were used to compare the effects of the MDTP on primary and secondary outcomes over time. A process evaluation was integrated into the RCT to explore the intervention fidelity and help to interpret how the intervention works.ResultsIn Phase I, the systematic review included 10 articles involving eight individual studies. Meta-analysis results revealed that dignity therapy significantly improved dignity‐related distress in existential distress domain (mean differences, MD: -0.26, 95% confidential interval, CI, -0.50 to -0.02, P=0.03) and social support distress domain (MD: -0.23, 95% CI, -0.39 to -0.07, P<0.01), but non-significantly improved depression. Narrative summaries indicated that dignity therapy exerted positive effects on patients' sense of dignity, depression, spiritual well-being and life satisfaction. The review also indicated the intervention design that dignity therapy could contain an explanation and reminiscence session within one week facilitated by nurses with professional training in dignity therapy. Research gaps were identified that the scarce research of dignity therapy for patients with cancer undergoing chemotherapy and cultural issues of its application in mainland China.In Phase II, 20 voluntary patients with cancer undergoing chemotherapy aged 28 to 70 years old completed the interviews. Perceived dignity themes were classified into three categories, namely, illness related concerns, dignity conserving repertoire and social dignity inventory. Communication openness between patients and family caregivers was an important new theme under the category of social dignity inventory which affected the perceived dignity of Chinese patients. The results of Phases I and II were used to guide the development of an evidence-based protocol.In Phase III, the outcome-based results demonstrated that the MDTP significantly decreased dignity-related distress (P=0.02), depression (P<0.00) and improved spiritual well-being (P=0.02), life satisfaction (P=0.04) for patients with lung cancer undergoing chemotherapy at the primary time point (week one). The qualitative data of 14 patients, 11 family caregivers and 11 nurses from the process evaluation confirmed the effectiveness of the MDTP in alleviating psychosocial distress and supplement other beneficial effects such as promoting personal relationship and increasing recovery confidence in fighting with the disease. Process evaluation showed the acceptable intervention fidelity that the intervention was well implemented in accordance with the protocol despite minor deviations such as shorter reminiscence time (approximately 30 minutes shorter than the protocol). The process evaluation also revealed some possible reasons for the significant effects of the MDTP, such as modifications in the MDTP involving family caregivers, the facilitators’ characteristics in professional knowledge and skills with supportive, attentive and dignified attributes, the simple and flexible procedure of the intervention.ConclusionThis study demonstrated a culturally sensitive and family-oriented MDTP delivered by a nurse is effective for Chinese patients with lung cancer undergoing chemotherapy to address dignity-related distress, depression and improve spiritual well-being and life satisfaction. The MDTP was well-accepted by patients and their family caregivers. Overall, the findings provide additional knowledge and evidence for the clinical implementation of dignified care to improve psychosocial well-being for patients with cancer undergoing chemotherapy.研究背景腫瘤的診斷和治療給患者帶來了身體症狀上和心理上的痛苦，使患者尊嚴受到損害甚至是尊嚴喪失。尊嚴療法（dignity therapy）是一種利用回憶來幫助患者維護尊嚴，緩解心理痛苦的社會心理干預方法。研究目的本研究旨在開發一種具有文化敏感性的社會心理干預，即改良尊嚴療法方案 (Modified Dignity Therapy Programme, MDTP)。以中國正在接受化療的肺癌患者為樣本，評估其在尊嚴、抑鬱、靈性狀況和生活滿意度方面的效果。研究方法本研究採取用於複雜干預評估的醫學研究理事會（ Medical Research Council, MRC）框架，並以埃裡克森的第八階段社會心理發展和尊嚴模型的整合為指導，本研究分為三個階段。第一階段是一個系統回顧，旨在研究尊嚴療法對腫瘤患者的尊嚴、抑鬱、靈性狀況和生活滿意度的影響。系統回顧揭示了尊嚴療法的干預模式。第一階段的結果用於指導基於證據的研究計畫的開發。第二階段為質性研究 (N=20)，旨在 探討接受化療的腫瘤患者對尊嚴的感知，並找出支持或破壞尊嚴的因素。質性研究設計採用面對面、半結構化和單獨訪談方法探討中國文化對尊嚴的影響。第三階段為主要研究，採用隨機對照試驗（Randomised Controlled Trial, RCT））(N=120)評估 MDTP的效果。在第一、二階段研究的基礎上，MDTP是一個涉及患者及其家庭照顧者為一體的以家庭為中心的社會心理干預。招募接受化療的肺癌患者(≥18歲 )隨機接受 MDTP或安慰對照。主要結果為尊嚴，次要結果包括抑鬱、靈性狀況和生活滿意度。採用廣義估計方程 (Generalised Estimating Equations, GEE)模型比較 MDTP在整個研究過程對主要和次要結果的影響。第三階段同時包含一個過程評估探索干預的保真度，並用來幫助解釋干預效果的產生。研究結果在第一階段，系統評價包括 10篇文章，涉及 8項獨立研究。薈萃分析結果顯示，尊嚴療法顯著改善了存在性困擾維度 (平均差[MD]:−0.26,95% CI，，−0.50至 −0.02 P=0.03)和社會支持維度(MD:−0.23,95% CI，，−0.39至 −0.07 P<0.01)中尊嚴相關的困擾，但 未顯著改善抑鬱。敘述性總結顯示，尊嚴療法對患者的尊嚴、抑鬱、靈性狀況和生活滿意度均有積極影響。該系統回顧顯示尊嚴療法是由經過專業尊嚴療法培訓的護士組織的，包含一個解釋和回憶期的，為期一周的社會心理干預。該回顧同時指出尊嚴療法缺乏以腫瘤化療患者為樣本的研究以及它在中國的應用可能存在文化相關問題。在第二階段， ，20例年齡在 28至 70歲的腫瘤化療患者自願完成了訪談。感知到的尊嚴主題可分為三類，即與疾病有關的因素、尊嚴維護技能因素和社會尊嚴因素。患者和家庭照顧者之間的溝通是影響中國患者尊嚴感知的重要因素。第一階段 和第二階段的結果被用來指導基於證據的研究計畫的開發。第三階段結果顯示， MDTP顯著降低了肺癌化療患者一周後的尊嚴困擾 (P=0.02)、抑鬱 (P