Developing and Testing of Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
2026年8月28日 更新者：Evelyn Arana, DrPH、Rutgers, The State University of New Jersey
Developing and Testing of Culturally Appropriate Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
This study focuses on improving insomnia among Hispanic cancer survivors.
The three goals are to (1) culturally adapt Body-Mind Training and Cognitive Behavioral Therapy for Insomnia (CBT-I) with input from Hispanic cancer survivors, (2) determine whether the two programs are feasible and acceptable, and (3) explore whether they improve insomnia.
研究概览
详细说明
This study focuses on improving insomnia among Hispanic cancer survivors by adapting and testing two culturally appropriate sleep programs.
First, up to 32 Hispanic cancer survivors will participate in four focus groups, with 6-8 participants per group, to provide feedback to help culturally adapt a Body-Mind Training (BMT) program and Cognitive Behavioral Therapy for Insomnia (CBT-I) in both English and Spanish.
Eight of these participants will also complete individual interviews to provide additional feedback on the adapted programs.
Second, 58 Hispanic cancer survivors with insomnia will participate in a randomized pilot study comparing BMT and CBT-I to determine whether the programs are feasible, acceptable, and practical for participants to complete.
Third, the study will explore whether BMT and CBT-I improve insomnia, using both participant-reported insomnia symptoms and objective sleep measures collected with a wrist-worn activity monitor.
Sleep will be assessed before the program, shortly after it ends, and three months later.
The findings will help inform the design of a larger study comparing these approaches for treating insomnia among Hispanic cancer survivors.
研究类型
介入性
注册 (估计的)
58
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Evelyn Arana, DrPH
- 电话号码：9086420861
- 邮箱：earana@cinj.rutgers.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Aim 1 (Cultural Adaptation):
Inclusion Criteria:
- Be 18 years of age or older
- Be at least 18 years old when received their cancer diagnosis
- Self-identify as Hispanic and/or Latino(a)
- Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy
- Completion of primary cancer treatment in the past 3 months - 5 years (may be on hormonal therapy and/or immunotherapy or other long-term therapies)
- Have sleep disturbance (indicated by a response of 3 or more on the MDASI sleep question by using an 11-point scale anchored by 0 [no sleep disturbance] and 10 [worst possible sleep disturbance]
- Be able to read and understand English and/or Spanish
Exclusion Criteria:
- Inability to speak and read English or Spanish proficiently
- Life expectancy <12 months
Aims 2-3 (RCT):
Inclusion Criteria:
- Be 18 years of age or older
- Self-identify as Hispanic and/or Latino(a)
- Have/had a confirmed diagnosis of a solid tumor or hematologic malignancy
- Completion of primary cancer treatment in the past 3 months - 5years (may be on hormonal therapy and/or immunotherapy or other long-term therapies) Report sleep difficulties ≥3 times per week for ≥3 months consistentwith DSM-5 insomnia criteria4,
- Must have a score of ≥10 on the Insomnia Severity Index
- Must have a personal mobile device (i.e., mobile smart phone, laptop, desktop computer, tablet) with active internet
- Be able to read and understand English and/or Spanish
- Physically Inactive (<150 minutes of vigorous exercise/week within the past 3 months)
Exclusion Criteria:
- Current or last year practice of TCQ or similar practices;
- Current or past CBT-I treatment,
- Shift worker,
- Life expectancy <12 months,
- Health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems.
- Participants with a history of diagnosed sleep apnea or restless leg syndrome (RLS) will be excluded from the study, as both increase the risk for insomnia. All other participants will complete the STOP-Bang Sleep Apnea Screening Tool and a single RLS screening question during screening, as both are underdiagnosed in Hispanics. Those scoring ≥ 5 on the STOP-Bang, indicating high risk for moderate-to-severe sleep apnea, or who respond with 'Yes' on the RLS risk tool, will also be excluded and referred to a sleep medicine specialist for evaluation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Body Mind Training
Body-Mind Training: A 12-week, group-based program delivered virtually twice per week.
Sessions combine gentle body movements, breathing exercises, meditation, and relaxation techniques designed to support sleep and overall well-being.
Participants are also encouraged to practice at home between sessions.
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Body-Mind Training (BMT): A 12-week, group-based program delivered by live videoconference twice per week for 60 minutes.
Each session includes a warm-up, gentle body movements combined with meditation, breathing techniques, and relaxation exercises.
Movements can be completed while seated or standing to support participant safety and different physical abilities.
Participants will also receive instructional videos and a manual to support home practice and will be encouraged to practice for at least 30 minutes, three days per week.
The final four weeks of the program will emphasize skill consolidation and continued practice.
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实验性的：Cognitive Behavioral Therapy - Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered virtually once per week.
Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention.
Participants are encouraged to practice the skills between sessions.
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Cognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered by live videoconference once per week for 60 minutes by a licensed bilingual psychologist experienced in CBT-I.
Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention.
Participants will be encouraged to practice the skills learned during sessions for at least 30 minutes per day, three days per week.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insomnia Severity Index
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Insomnia will be assessed with the Insomnia Severity Index (ISI).
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
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Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
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Recruitment Rate
大体时间：1-2 weeks post-intervention
|
We hypothesize that at least 50% of eligible individuals approached for the study will enroll.
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1-2 weeks post-intervention
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Follow-up retention rate
大体时间：1-2 weeks post-intervention
|
We hypothesize that ≥80% of participants will complete the 1-week post-intervention assessment and ≥70% will complete the 3-month post-intervention assessment.
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1-2 weeks post-intervention
|
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Actigraphy adherence rate
大体时间：baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data
|
baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Physical activity and sleep logs adherence rate
大体时间：baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
we hypothesize that )≥70% of participants will complete ≥75% of activity & sleep logs.
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baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Acceptability
大体时间：1-2 weeks post-intervention
|
Acceptability will be assessed using the Treatment Perceptions Questionnaire (TPS).
Participants will rate the comprehensibility of components of the culturally appropriate interventions, as well as their length, intensity, and overall suitability for reducing sleep-quality impairment.
The TPQ is available in Spanish and English.
We hypothesize that ≥80% of participants will find the intervention was acceptable
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1-2 weeks post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pittsburgh Sleep Quality Index
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Pittsburgh Sleep Quality Index (PSQI).
The PSQI is a widely used, validated 19-item self-report measure of sleep quality over the past month.
It yields a global score ranging from 0-21, with higher scores indicating poorer sleep quality and scores >5 indicating clinically significant sleep disturbance.
The PSQI has demonstrated good internal consistency (Cronbach's α = 0.83), test-retest reliability, and construct validity.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Sleep self-efficacy
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Sleep self-efficacy will be measured with the sleep self-efficacy scale(SES).
The SES is a 9-item self-report measure that assesses anindividual's confidence in their ability to achieve and maintain healthysleep.
Items are rated on a 5-point Likert scale, with higher scoresindicating greater sleep self-efficacy.106
The SES has demonstratedexcellent internal consistency (Cronbach's α ≈ 0.90).
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Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Mindfulness
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Mindfulness will be measured with the Mindful Attention Awareness Scale (MAAS), a 15-item self-report measure that assesses dispositional mindfulness, specifically an individual's awareness of and attention to present-moment experiences.
Items are rated on a 6-point Likert scale, with higher scores indicating greater mindfulness.
The MAAS has demonstrated excellent internal consistency (Cronbach's α =0.80-0.90)
and strong construct validity and is available in both English and Spanish
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Physical Activity Level
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Differences in physical activity outside theintervention will be assessed with the Godin-Shephard Leisure-TimePhysical Activity Questionnaire.
This questionnaire is available andvalidated in English and Spanish.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Quality of Life (QOL)
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Quality of Life (QOL) will be assessed via the Functional Outcomes for Cancer Therapy - General (FACT-G).
This measure consists of 27 items designed to measure four domains of quality of life in cancer patients: physical, social, emotional, and functional well-being.
Coefficients of reliability and validity are uniformly high.
The scale's ability to discriminate among patients based on disease stage, performance status rating (PSR), and hospitalization status supports its sensitivity.
It has also demonstrated sensitivity to change over time.
The FACT-G is available and validated in English and Spanish.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Anxiety and Depressive Symptoms
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Anxiety and depression will be measured with the Patient Health Questionnaire-4 (PHQ-4), a 4-item self-report measure that assesses symptoms of anxiety and depression over the past two weeks.
It combines the 2-item Generalized Anxiety Disorder scale (GAD-2) and the 2-item Patient Health Questionnaire (PHQ-2), with higher scores indicating greater psychological distress.
The PHQ-4 has demonstrated good internal consistency (Cronbach's α ≈ 0.81) and strong validity and is available in both English and Spanish.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Perceived Stress
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Perceived stress will be measured with the Perceived Stress Scale (PSS-10), a 10-item self-report measure that assesses the degree to which individuals perceive their lives as stressful during the past month.
Items are rated on a 5-point Likert scale, with higher scores indicating greater perceived stress.
The PSS-10 has demonstrated good internal consistency (Cronbach's α ≈ 0.78-0.91),
strong construct validity, and is available in both English and Spanish.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Fatigue
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Fatigue will be assessed with the Functional Assessment of Chronic Illness - Fatigue (FACIT-F) Scale.120
This scale is frequently used with cancer survivors because it has established minimally important differences.
This 13-item scale assesses the level of fatigue during usual activities over the past 7 days, with higher scores indicating less fatigue (score range=0-52; Cronbach's alpha=0.86).
The FACIT-F is available in English and Spanish and validated in Spanish-speaking populations.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
|
Comorbidities
大体时间：Baseline
|
Comorbidities will be assessed with the Charlson Comorbidity Index.
It is a weighted index that considers both the number and the seriousness of comorbid diseases.
It consists of 19 items, each with an assigned weight from 1 to 6 according to the relative risk of dying within a year.
In general, the absence of comorbidity is considered: 0-1 points; low comorbidity: 2 points; and high comorbidity:≥3 points.
|
Baseline
|
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Acculturation
大体时间：Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
Acculturation will be measured with the Short Acculturation Scale for Hispanics (SASH).
The 12-item scale (explaining 67.6% of the variance for Hispanics) correlates highly with the following validation criteria: respondents' generation, length of residence in the U.S., age at arrival, ethnic self-identification, and an acculturation index.
The SASH is available and validated in English and Spanish.
|
Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
|
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Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
大体时间：3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
Actigraphy will measure the number of minutes of actual sleep.
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3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
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Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
大体时间：3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
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3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
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Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy
大体时间：3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
Actigraphy will measure the minutes it takes for the participant to fall asleep.
|
3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
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Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy
大体时间：3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
Actigraphy will measure total minutes of wake time after sleep onset.
|
3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
|
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Perceived exertion
大体时间：Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.
|
Perceived exertion will be measured after each BMT session, with the classic Borg Rating of Perceived Exertion (RPE) scale, which is a 15-point scale (ranging from 6 to 20).
It has been extensively tested and validated against physiological markers.
This will be collected to ensure that the BMT intervention is perceived as being of mild to moderate intensity.
|
Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.
|
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Treatment Credibility and Expectancy
大体时间：During the first week of the intervention
|
Credibility/Expectancy Questionnaire (CEQ).
The CEQ is a brief 6-item self-report measure assessing participants' perceived credibility of an intervention and expectations for improvement.
It has demonstrated good internal consistency, with Cronbach's α generally ranging from 0.79-0.90
for credibility and 0.81-0.86 for expectancy, as well as good test-retest reliability.
|
During the first week of the intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Evelyn Arana, DrPH、Rutgers Cancer Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月2日
初级完成 (估计的)
2031年7月1日
研究完成 (估计的)
2031年7月1日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年8月28日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月28日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.