研究动态
Articles below are published ahead of final publication in an issue. Please cite articles in the following format: authors, (year), title, journal, DOI.

一项顺序多次分配的随机试验,旨在研究化疗后的症状管理。

A sequential multiple assignment randomized trial of symptom management after chemotherapy.

发表日期:2023 Feb 16
作者: Alla Sikorskii, Terry Badger, Chris Segrin, Tracy E Crane, Pavani Chalasani, Waqas Arslan, Mary Hadeed, Kristin E Morrill, Charles Given
来源: JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

摘要:

许多癌症幸存者在化疗后会经历持续的症状负担。在这个序贯多重分配随机试验中,我们测试了两种基于证据的症状管理干预的最佳排序。固体肿瘤幸存者(N=451)在基线时进行了访谈,并根据合并发病率和抑郁症状的需求水平进行分层。高需求幸存者最初被随机分配到12周的症状管理和生存手册(SMSH,N=282)或12周的SMSH,并在第1-8周增加8周的电话人际咨询(TIPC,N=93)。在仅进行4周SMSH后,抑郁症状未得到缓解的人重新随机分配,继续仅使用SMSH(N=30)或增加TIPC(N=31)。在随机分配的组和三个动态治疗方案(DTR)的1-13周中,比较了抑郁症状的严重程度和其他17种症状的总和的严重程度:1)SMSH为12周;2)从第1周开始SMSH为12周并添加8周的TIPC;3)SMSH为4周,如果在第4周SMSH单独对抑郁症状没有反应,则随后使用SMSH + TIPC 8周。没有随机分配的臂或DTR的主要效应,但在第一次随机分配的前4周和第二次随机分配时,有一个显著的与基线抑郁症状相互作用的试验臂,支持SMSH单独治疗。SMSH可以代表简单、有效的症状管理选项,仅在抑郁症状升高和多种合并发病率的人没有对SMSH单独治疗作出反应时,才添加TIPC。版权所有©2023美国临终和缓和医学会。由Elsevier Inc.出版。保留所有权利。
Many cancer survivors experience a lingering symptom burden after chemotherapy.In this sequential multiple assignment randomized trial, we tested optimal sequencing of two evidence-based interventions for symptom management.Survivors of solid tumors (N=451) were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH with 8 weeks of Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31). Severity of depression and summed severity index of 17 other symptoms over weeks 1-13 were compared between randomized groups and among three dynamic treatment regimes (DTRs): 1) SMSH for 12 weeks; 2) SMSH for 12 weeks with 8 weeks of TIPC from week 1; 3) SMSH for 4 weeks followed by SMSH+TIPC for 8 weeks if no response to the SMSH alone on depression at week 4.There were no main effects for randomized arms or DTRs, but there was a significant interaction of trial arm with baseline depression favoring SMSH alone during weeks 1-4 in the first randomization and SMSH+TIPC in the second randomization.The SMSH may represent a simple effective option for symptom management, adding TIPC only when there is no response to SMSH alone for people with elevated depression and multiple co-morbidities.Copyright © 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.