Developing and Testing of Culturally Appropriate Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Body Mind Training (Behavioral)
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.
干预措施: Cognitive Behavioral Therapy - Insomnia (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: 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.
Recruitment Rate
时间窗: 1-2 weeks post-intervention
We hypothesize that at least 50% of eligible individuals approached for the study will enroll.
Follow-up retention rate
时间窗: 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.
Actigraphy adherence rate
时间窗: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data
Physical activity and sleep logs adherence rate
时间窗: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
we hypothesize that )≥70% of participants will complete ≥75% of activity \& sleep logs.
Acceptability
时间窗: 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
次要结局
- Pittsburgh Sleep Quality Index(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Sleep self-efficacy(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Mindfulness(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Physical Activity Level(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Quality of Life (QOL)(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Anxiety and Depressive Symptoms(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Perceived Stress(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Fatigue(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Comorbidities(Baseline)
- Acculturation(Baseline, 1-2 weeks post-intervention, and 3 months post-intervention)
- Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy(3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention))
- Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy(3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention))
- Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy(3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention))
- Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy(3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention))
- Perceived exertion(Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.)
- Treatment Credibility and Expectancy(During the first week of the intervention)
研究者
Evelyn Arana, DrPH
Assistant Professor
Rutgers, The State University of New Jersey