Symptom Cluster Assessment and Intervention Trial

描述（由申请人提供）：我们建议对症状聚类干预进行探索性混合方法研究。干预措施将根据自我报告的症状严重程度超过特定阈值，为四种目标症状（疲劳、失眠、疼痛和抑郁）中的任何一种提供症状评估和管理。参与者还将接受适应性剂量的干预，其中干预的频率和次数取决于每次干预中报告的症状的严重程度。本研究的目的是：1)了解症状群在症状干预过程中变化的特征；2)描述干预过程，包括干预的量或剂量及其对症状结局的影响；干预前（人口统计学、临床特征和个人属性）和干预内因素（症状严重程度变化和推荐干预措施的使用）可以预测症状干预剂量和结果；3)在定性访谈中，探讨患者对干预体验的看法。81名女性乳腺癌患者的最终样本将被纳入研究。符合条件的个体将被邀请在化疗的第一个周期（第一阶段）完成症状日记。进入研究的干预部分（第2阶段）将仅限于症状日记表明至少有两种目标症状升高的个体。在四个化疗周期中，干预参与者将接受量身定制的症状群集干预；干预的剂量（次数和频率）将根据症状严重程度的变化而调整。在每个化疗周期结束时，将使用随访问卷来评估结果。最后的访谈将探讨被试对症状集群干预后的体验的看法。单变量和多变量统计以及定性分析将用于检验研究目的。这项研究有可能告知我们对有效的症状群管理的理解；它还将指导未来的干预试验，以检查量身定制的适应性干预的有效性。与公共卫生的相关性：与公共卫生的相关性接受治愈性和姑息性治疗的癌症患者经常受到多种相互关联的症状的困扰，这些症状干扰了他们的功能并限制了他们的生活质量。包括疲劳、失眠、疼痛和抑郁在内的症状群将在量身定制的症状干预的背景下进行检查。提出的探索性研究将扩大我们对症状群的科学理解，因为它在癌症治疗和量身定制的症状管理的背景下发生了变化，肿瘤护士根据患者的需要调整干预剂量。

DESCRIPTION (provided by applicant): We propose to conduct an exploratory mixed method study of a symptom cluster intervention. The intervention will be tailored to provide symptom assessment and management for any of four target symptoms (fatigue, insomnia, pain, and depression) based on self-reported symptom severity that exceeds a specific threshold. Participants will also receive an adaptive dose of intervention in which the frequency and number of intervention sessions is determined by the severity of the symptoms reported in each intervention session. The aims of the study are to: 1) understand the characteristics of a symptom cluster as it changes over the course of a symptom intervention; 2) characterize the intervention process including amount or dose of intervention and its effect on symptom outcomes; and pre- intervention (demographics, clinical characteristics, and personal attributes) and within- intervention factors (symptom severity changes and use of recommended interventions) that could predict symptom intervention dose and outcomes; and 3) in qualitative interviews, explore patient perceptions of the intervention experience. A final sample of 81 female breast cancer participants will be recruited into the study. Eligible individuals will be invited to complete a symptom diary during the first cycle of chemotherapy (phase 1). Entry into the intervention portion of the study (phase 2) will be limited to individuals whose symptom diary indicates that at least two of the target symptoms were elevated. Over four cycles of chemotherapy, intervention participants will receive a tailored symptom cluster intervention; the dose of intervention (number and frequency of sessions) will be adapted according to changes in symptom severity. Follow-up questionnaires to evaluate outcomes will be administered at the end of each chemotherapy cycle. A final interview will be conducted to explore participants' views of the symptom cluster intervention experience as it was modified by the symptom cluster intervention. Univariate and multivariate statistics as well as qualitative analysis will be used to examine the study aims. This research has the potential to inform our understanding of effective symptom cluster management; it will also guide future intervention trials that examine the efficacy of a tailored adaptive intervention. PUBLIC HEALTH RELEVANCE: Relevance to Public Health Cancer patients undergoing curative and palliative therapies are often bothered by multiple interrelated symptoms that interfere with their functioning and limit their quality of life. A symptom cluster that includes fatigue, insomnia, pain, and depression will be examined in the context of a tailored symptom intervention. The proposed exploratory study will broaden our scientific understanding of a symptom cluster as it changes in the context of cancer therapy and tailored symptom management in which the oncology nurse adapts the dose of intervention to patient need.