在线接受与承诺疗法干预“拥抱痛苦”对患有慢性疼痛化疗诱导性周围神经病变的癌症幸存者的有效性：一项随机对照试验的研究方案。
Effectiveness of the online Acceptance and Commitment Therapy intervention "Embrace Pain" for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial.
机构信息
CoRPS - Center of Research on Psychological disorders and Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg University, PO Box 90153, Tilburg, 5000 LE, The Netherlands.
Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.
出版信息
Trials. 2022 Aug 9;23(1):642. doi: 10.1186/s13063-022-06592-3.
BACKGROUND
About 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy. This condition, for which treatment options are scarce, comes with limitations in daily life functioning and decreased quality of life. The current study examines the effectiveness of an online self-help intervention based on Acceptance and Commitment Therapy (ACT) in comparison to a waiting list condition (WLC) to deal with CIPN. In addition, it examines which factors moderate effects and to what extent the effects differ between guided and unguided ACT intervention.
METHODS
A two-parallel, non-blinded randomized controlled trial (RCT) will be carried out. Adult cancer survivors who experience painful CIPN for at least 3 months and completed chemotherapy at least 6 months ago will be recruited (n=146). In the intervention condition, participants will follow an 8-week self-management course containing 6 modules regarding psychoeducation and ACT processes, including therapeutic email guidance. By means of text and experiential exercises, supplemented with illustrations, metaphors, and audio files, people will learn to carry out value-oriented activities in their daily life with pain. Participants will learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Participants in the WLC will be invited to follow the intervention without therapeutic guidance 5 months after start. Pain interference is the primary outcome, while psychological distress, quality of life, CIPN symptom severity, pain intensity, psychological flexibility, mindfulness skills, values-based living, and pain catastrophizing will serve as secondary outcomes. All outcome measures will be evaluated at inclusion and baseline, early-intervention, mid-intervention, post-treatment, and 3- and 6-month post-treatment. Qualitative interviews will be conducted post-treatment regarding experiences, usage, usability, content fit, and satisfaction with the intervention.
DISCUSSION
This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05371158 . Registered on May 12, 2022.
PROTOCOL VERSION
version 1, 24-05-2022.
背景
约 30%的癌症幸存者在化疗结束后 6 个月以上仍患有化疗引起的周围神经病（CIPN）。这种情况治疗选择有限，会限制日常生活功能并降低生活质量。目前的研究检查了基于接受与承诺疗法（ACT）的在线自助干预与等待名单条件（WLC）相比治疗 CIPN 的有效性。此外，它还检查了哪些因素可以调节效果，以及指导性和非指导性 ACT 干预之间的效果差异程度。
方法
将进行一项两平行、非盲随机对照试验（RCT）。招募至少经历过 3 个月疼痛性 CIPN 且化疗至少 6 个月前已完成的成年癌症幸存者（n=146）。在干预组中，参与者将参加一个 8 周的自我管理课程，其中包含 6 个模块，包括心理教育和 ACT 过程，包括治疗性电子邮件指导。通过文本和体验式练习，辅以插图、隐喻和音频文件，人们将学习在日常生活中带着疼痛开展以价值为导向的活动。参与者将学习应对疼痛的新方法，包括减少疼痛回避和增加疼痛接受。WLC 组的参与者将在开始后 5 个月被邀请在没有治疗指导的情况下参加干预。疼痛干扰是主要结局，而心理困扰、生活质量、CIPN 症状严重程度、疼痛强度、心理灵活性、正念技能、基于价值的生活和疼痛灾难化将作为次要结局。所有结局测量将在纳入和基线时、早期干预时、中期干预时、治疗后以及 3 个月和 6 个月治疗后进行评估。治疗后将进行定性访谈，了解干预的经验、使用情况、可用性、内容适宜性和满意度。
讨论
这项研究将提供有关基于 ACT 的在线自助干预与 WLC 治疗慢性疼痛性 CIPN 患者的有效性的有价值信息。
试验注册
ClinicalTrials.gov NCT05371158。注册于 2022 年 5 月 12 日。
方案版本
第 1 版，2022 年 5 月 24 日。
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