Moviendo Las Caderas: Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
The primary objective is to assess the feasibility, acceptability and explore the impact of a culturally appropriate Latin Dance intervention vs. Usual Care on sleep quality for Hispanic cancer survivors.
Secondary objectives are to examine the preliminary efficacy of a culturally appropriate Latin Dance intervention on secondary cancer- and treatment-related side effects (e.g., Quality of Life, distress, insomnia, fatigue).
详细描述
In this feasibility Randomized Control Trial (RCT) study, the investigators will assess the feasibility, acceptability, and explore the impact of a Latin dance intervention vs usual care on sleep quality among Hispanic survivors.
Study Aims:
Aim 1: Develop a culturally appropriate Latin dance intervention for Hispanic cancer survivors using a bidirectional community engagement approach. Using iterative qualitative feedback from Hispanic cancer survivors, the investigators will develop a Latin dance intervention for Hispanic cancer survivors.
Aim 2: Assess the feasibility and acceptability of a culturally appropriate Latin Dance intervention for Hispanic cancer survivors.
Aim 3: Provide preliminary evidence of the efficacy potential of a culturally appropriate Latin Dance intervention vs. usual care on subjective and objective sleep quality for Hispanic 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
- •Be 18 years of age or older
- •Self-identify as Hispanic and/or Latino(a)
- •Have a confirmed diagnosis of a solid tumor or hematologic malignancy
- •Must have completed primary cancer treatment 3+ months prior to enrollment (e.g., chemotherapy, surgery, and/or radiation therapy but 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 MD Anderson Symptom Inventory 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
- •Physically Inactive (<150 minutes of vigorous exercise/week within the past 3 months)
排除标准
- •Current regular Latin dancing practice within the past year (2-3 times a week over a period of two months that is not interrupted).
- •Inability to speak and read English or Spanish proficiently
- •Inability to understand informed consent
- •Medical conditions that can cause sleep impairment: sleep apnea, restless leg syndrome, shift work
- •Regular use of a walker or wheelchair
- •Healing or unhealed fractures
- •Heart failure
- •Life expectancy <12 months
- •Unwilling to be randomized to study arms and/or commit to 8 weeks of classes and a follow-up assessment
研究组 & 干预措施
Usual care arm
Participants in the usual care arm will receive care as usual and will not participate in the Latin Dancing program.
Intervention arm
Participants in this arm will participate in the virtual Latin Dance group program that meets for 8 weeks, 2x each week, for 75 minute sessions.
干预措施: Latin Dance (Behavioral)
结局指标
主要结局
Feasibility of the Intervention
时间窗: 8 weeks
Feasibility in this study will include recruitment, adherence, and retention rates.
Treatment Perception Questionnaire (Acceptability of Intervention)
时间窗: Post-intervention (at approximately 8 weeks)
Acceptability is defined as at least 80% of participants in the Latin Dance group agreeing or strongly agreeing that the intervention was acceptable via the Treatment Perceptions Questionnaire (TPQ). The TPQ consists of 10 statements about treatment satisfaction on a Likert-type scale from 0 (strongly disagree) to 4 (strongly agree). Average scores ≥ 3 indicated acceptable satisfaction.
Pittsburgh Sleep Quality Index
时间窗: Baseline and post-intervention (approximately 8 weeks)
Changes in sleep quality will be assessed pre and post-intervention with the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality.
Feasibility of the Intervention
时间窗: 8 weeks
Feasibility in this study will include recruitment, adherence, and retention rates.
Treatment Perception Questionnaire (Acceptability of Intervention)
时间窗: Post-intervention (at approximately 8 weeks)
Acceptability is defined as at least 80% of participants in the Latin Dance group agreeing or strongly agreeing that the intervention was acceptable via the Treatment Perceptions Questionnaire (TPQ). The TPQ consists of 10 statements about treatment satisfaction on a Likert-type scale from 0 (strongly disagree) to 4 (strongly agree). Average scores ≥ 3 indicated acceptable satisfaction.
Pittsburgh Sleep Quality Index
时间窗: Baseline and post-intervention (approximately 8 weeks)
Changes in sleep quality will be assessed pre and post-intervention with the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality.
次要结局
- Charleson Comorbidity Index(Baseline and post-intervention (approximately 8 weeks))
- Physical Activity Daily Diaries(Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.)
- Functional Outcomes for Cancer Therapy - General(Baseline and post-intervention (approximately 8 weeks))
- Functional Assessment of Chronic Illness - Fatigue(Baseline and post-intervention (approximately 8 weeks))
- Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Sleep Daily Diaries(Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.)
- Brief Pain Inventory (BPI)(Baseline and post-intervention (approximately 8 weeks))
- Leisure Time Exercise Questionnaire of Godin and Shephard(Baseline and post-intervention (approximately 8 weeks))
- Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Functional Outcomes for Cancer Therapy - General(Baseline and post-intervention (approximately 8 weeks))
- Functional Assessment of Chronic Illness - Fatigue(Baseline and post-intervention (approximately 8 weeks))
- Patient Health Questionnaire - 2 (PHQ-2)(Baseline and post-intervention (approximately 8 weeks))
- Generalized Anxiety Disorder - 7 (GAD-7)(Baseline and post-intervention (approximately 8 weeks))
- Insomnia Severity Index(Baseline and post-intervention (approximately 8 weeks))
- Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy(2 weeks (worn for 1 week at Baseline and 1 week at post-intervention))
- Charleson Comorbidity Index(Baseline and post-intervention (approximately 8 weeks))
- Physical Activity Daily Diaries(Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.)
- Sleep Daily Diaries(Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.)
- Self-Efficacy for Exercise (SEE) Scale(Baseline and post-intervention (approximately 8 weeks))
- Short Acculturation Scale for Hispanics (SASH)(Baseline)
- Discrimination in Medical Settings Scale(Baseline and post-intervention (approximately 8 weeks))
研究者
Evelyn Arana, DrPH
Assistant Professor
Rutgers, The State University of New Jersey