A Crossover Randomized Controlled Trial to Investigate the Acceptability and Efficacy of Cecebot, a Conversational Agent for Insomnia After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment discontinuation rate
研究概览
简要总结
This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.
详细描述
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations once weekly (QW), and wear activity tracker daily on weeks 1-6.
GROUP II (WAITLIST CONTROL): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 80 years
- •Prior diagnosis of stage I-III invasive breast cancer
- •Female gender
- •Clinically significant insomnia symptoms, defined as a Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8 T-score of 55 or greater
- •Insomnia complaints lasting ≥ 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating ability to perform activities of daily living
- •Own a smartphone with Internet connectivity
- •Willing and able to complete the intervention with personal smartphone
- •Proficient in speaking and reading English
- •Completed breast cancer treatment within past 5 years
排除标准
- •Prior diagnosis of restless leg syndrome, periodic leg movement disorder, narcolepsy, or rapid eye movement (REM) behavior disorder
- •Current sleep apnea (treated or untreated)
- •Current shiftwork
- •Actively receiving chemotherapy or radiation (endocrine therapy permitted)
- •Previously received CBTi therapy with a professional therapist
- •Contraindications to CBTi including:
- •Active psychosis
- •Uncontrolled bipolar disorder
- •Severe depression
- •Active substance use disorder (moderate or greater severity)
- •Use of prescribed sleep medication > 3 times per week
- •Previously participated in user testing of the study intervention (Cecebot)
- •Unwilling or unable to complete study procedures
研究组 & 干预措施
GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
干预措施: Cognitive Behavior Therapy for Insomnia (Behavioral)
GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
干预措施: Text Message-Based Navigation Intervention (Other)
GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
干预措施: Cognitive Behavior Therapy for Insomnia (Behavioral)
GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
干预措施: Internet-Based Intervention (Other)
GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
干预措施: Medical Device Usage and Evaluation (Other)
GROUP I (Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
干预措施: Questionnaire Administration (Other)
GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
干预措施: Internet-Based Intervention (Other)
GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
干预措施: Medical Device Usage and Evaluation (Other)
GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
干预措施: Questionnaire Administration (Other)
GROUP II (waitlist control, Cecebot intervention)
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
干预措施: Text Message-Based Navigation Intervention (Other)
结局指标
主要结局
Treatment discontinuation rate
时间窗: Up to week 6 of intervention
Defined as the proportion of all treatment participants who permanently stop the intervention prior to week 6 for any reason. An all-cause discontinuation rate of 40% or less will be considered a threshold for acceptability.
次要结局
- Recruitment rates(Up to week 12)
- Lost to follow-up(Up to week 12)
- Adherence to physical activity (PA) recommendation(Up to week 12)
- AE rate(At week 6 of intervention)
- Incidence of adverse events (AEs)(Up to week 12)
- Enrollment rate(Up to week 12)
- Intervention engagement(Up to week 12)
- Adherence to sleep recommendations(Up to week 12)
- Data entry adherence(Up to week 12)
- Sleep quality and the impact of insomnia(At week 0, 6 and 12)