Greeley Krista M, Lee Rachel M, Tulk Joshua, Harding Scott V, Yi Yanqing, Aubrey-Bassler Kris, Garland Sheila N
Department of Psychology, Faculty of Science, Memorial University, 232 Elizabeth Ave, St. John's, NL A1B 3X9 Canada.
Department of Biochemistry, Faculty of Science, Memorial University, St. John's, NL Canada.
Sleep Sci Pract. 2025;9(1):10. doi: 10.1186/s41606-025-00129-8. Epub 2025 May 10.
BACKGROUND/AIMS: Sleep disturbances are one of the biggest barriers to resuming normal functioning following cancer treatment. Cognitive behavioral therapy for insomnia (CBT-I) has demonstrated efficacy in cancer survivors but few studies have recorded adverse events (AEs) that occur during treatment. The purpose of this study was to report the prevalence, severity, and attribution of AEs during CBT-I with cancer survivors.
Cancer survivors from Atlantic Canada with insomnia and comorbid cognitive impairment were recruited to participate in a randomized controlled trial of CBT-I. Participants reported the prevalence, severity, and attribution of AEs at mid-treatment (4 weeks) and post-treatment (8 weeks). The likeliness of AEs being related to treatment was also rated by an independent clinician.
Of the 122 cancer survivors who completed treatment ( = 60.3, 77.9% women), 72 reported a total of 197 AEs. At mid-treatment, participants reported 113 AEs, but only 11 were rated as being attributed to the intervention. At post-treatment, participants did not report any AEs attributed to the intervention. An independent rater attributed more AEs to the treatment than the participants at both time points (4 weeks: 16 vs. 11, 8 weeks: 1 vs. 0). Gender ( = .014) and pre-treatment anxiety ( < .001) were associated with reporting an AE.
CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be attributed to the treatment. Clinicians should continue to recommend CBT-I as the first-line treatment for cancer survivors experiencing insomnia symptoms.
This study is a secondary analysis of a randomized controlled trial titled 'Addressing Cancer Treatment-Related Insomnia Online in Atlantic Canada (ACTION) study' (https://www.clinicaltrials.gov/search?cond=NCT04026048 identifier: NCT04026048).
背景/目的：睡眠障碍是癌症治疗后恢复正常功能的最大障碍之一。失眠的认知行为疗法（CBT-I）已在癌症幸存者中显示出疗效，但很少有研究记录治疗期间发生的不良事件（AE）。本研究的目的是报告癌症幸存者在CBT-I治疗期间不良事件的发生率、严重程度和归因。
招募来自加拿大大西洋地区患有失眠和合并认知障碍的癌症幸存者，参与一项CBT-I的随机对照试验。参与者在治疗中期（4周）和治疗后（8周）报告不良事件的发生率、严重程度和归因。一名独立的临床医生也对不良事件与治疗相关的可能性进行了评分。
在122名完成治疗的癌症幸存者中（平均年龄=60.3岁，77.9%为女性），72人报告了总共197起不良事件。在治疗中期，参与者报告了113起不良事件，但只有11起被评为与干预措施有关。在治疗后，参与者没有报告任何与干预措施有关的不良事件。在两个时间点上，一名独立评估者认为与治疗有关的不良事件比参与者报告的更多（4周：16起对11起，8周：1起对0起）。性别（P=0.014）和治疗前焦虑（P<0.001）与报告不良事件有关。
CBT-I是一种安全的治疗方法，癌症幸存者对其耐受性良好。大多数参与者没有经历可归因于治疗的不良事件。临床医生应继续推荐CBT-I作为有失眠症状的癌症幸存者的一线治疗方法。
本研究是一项名为“在加拿大大西洋地区在线解决癌症治疗相关失眠（ACTION）研究”的随机对照试验的二次分析（https://www.clinicaltrials.gov/search?cond=NCT04026048 标识符：NCT04026048）。
