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综合肿瘤学临床试验中与退出相关的因素:一项正在进行的基于正念的癌症康复与太极拳/气功对癌症健康的比较有效性试验的中期分析(MATCH研究)

Factors related to dropout in integrative oncology clinical trials: interim analysis of an ongoing comparative effectiveness trial of mindfulness-based cancer recovery and Tai chi/Qigong for cancer health (The MATCH study).

作者信息

Oberoi Devesh, Piedalue Katherine-Ann L, Pirbhai Hassan, Guirguis Steven, Santa Mina Daniel, Carlson Linda E

机构信息

Psychosocial Resources, Tom Baker Cancer Centre, Holy Cross Site Phase I, 2202-2 St SW, Calgary, AB, T2S 3C1, Canada.

Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Health Sciences Centre Foothills Campus, 3330 Hospital Drive NW, Calgary, T2N 4N1, AB, Canada.

出版信息

BMC Res Notes. 2020 Jul 17;13(1):342. doi: 10.1186/s13104-020-05172-5.

Abstract

OBJECTIVE

To examine the factors associated with loss to follow-up (LTFU) in an ongoing preference-based randomized waitlist controlled trial of mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ) for cancer survivors (the MATCH Study). Hierarchical logistic regression was used to determine the factors associated with LTFU. Predictors included adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM} vs. waitlist control {WLC} group).

RESULTS

Data indicated that randomization to the WLC group and, once in the intervention, low adherence were the main predictors of LTFU. Participants in the WLC group were 4 times more likely to be LTFU post-randomization [OR 3.96, 95% CI 2.08-7.56, p < 0.005] than those in the IM group. Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57-13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53-10.02, p = 0.01].

摘要

目的

在一项正在进行的基于偏好的随机等待名单对照试验中,研究与失访(LTFU)相关的因素。该试验针对癌症幸存者开展基于正念的癌症康复(MBCR)和太极/气功(TCQ)的研究(MATCH研究)。采用分层逻辑回归确定与失访相关的因素。预测因素包括治疗依从性、偏好与随机分组、干预类型(MBCR与TCQ)以及项目时间安排(立即干预组{IM}与等待名单对照组{WLC})。

结果

数据表明,随机分配到WLC组以及一旦进入干预阶段后依从性低是失访的主要预测因素。随机分组后,WLC组的参与者失访可能性是IM组的4倍[比值比(OR)3.96,95%置信区间(CI)2.08 - 7.56,p < 0.005]。治疗依从性低的参与者在干预后失访可能性是6倍[5.87(2.57 - 13.400;p < 0.005],在干预6个月后失访可能性是4倍[OR 3.93,95% CI 1.53 - 10.02,p = 0.01]。

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