- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06844981
Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
Moviendo Las Caderas: Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Evelyn Arana, DrPH
- Phone Number: 908-642-0861
- Email: earana@CINJ.Rutgers.edu
Study Contact Backup
- Name: Arlette Chavez, MD
- Phone Number: 732-715-4923
- Email: ac2758@CINJ.Rutgers.edu
Study Locations
-
-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care arm
Participants in the usual care arm will receive care as usual and will not participate in the Latin Dancing program.
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Experimental: 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.
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Latin Dance intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Perception Questionnaire (Acceptability of Intervention)
Time Frame: 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.
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Post-intervention (at approximately 8 weeks)
|
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Pittsburgh Sleep Quality Index
Time Frame: 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.
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Baseline and post-intervention (approximately 8 weeks)
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Feasibility of the Intervention
Time Frame: 8 weeks
|
Feasibility in this study will include recruitment, adherence, and retention rates.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Outcomes for Cancer Therapy - General
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
Quality of Life 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 physical, social, and functional domain scores range from 0-28 with higher scores indicating better quality of life.
The emotional domain score ranges from 0 - 24 with higher scores indicating better quality of life.
The FACT-G total score ranges from 0 - 108, with higher scores indicating better quality of life.
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Baseline and post-intervention (approximately 8 weeks)
|
|
Functional Assessment of Chronic Illness - Fatigue
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
Fatigue will be assessed with the Functional Assessment of Chronic Illness - Fatigue (FACIT-F) Scale.
Higher scores indicate less fatigue (score range=0-52).
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Baseline and post-intervention (approximately 8 weeks)
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Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
Time Frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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Actigraphy will measure the number of minutes of actual sleep.
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2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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|
Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy
Time Frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
|
Actigraphy will measure total minutes of wake time after sleep onset.
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2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
|
|
Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
Time Frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
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2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy
Time Frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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Actigraphy will measure the minutes it takes for the participant to fall asleep.
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2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
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|
Charleson Comorbidity Index
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
The Charleson Comorbidity Index 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.
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Baseline and post-intervention (approximately 8 weeks)
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Physical Activity Daily Diaries
Time Frame: Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
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The physical activity daily diary is designed to gather information about participants' daily physical activity patterns.
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Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
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Sleep Daily Diaries
Time Frame: Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
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The sleep diary is designed to gather information about participants' daily sleep patterns.
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Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
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Patient Health Questionnaire - 2 (PHQ-2)
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
The PHQ-2 is a two-item screening questionnaire for depression that asks about the frequency of a depressed mood and loss of interest or pleasure in the last two weeks.
Each of the two questions is scored from 0 to 3, based on frequency.
The two scores are added together for a total score ranging from 0 to 6.
A total score of 3 or higher indicates a positive screen for depression.
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Baseline and post-intervention (approximately 8 weeks)
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Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame: Baseline and post-intervention (approximately 8 weeks)
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The GAD-7 is used for screening and measuring the severity of generalized anxiety disorder (GAD).
The total score indicates the severity of anxiety, from minimal (0-4) to severe (15 and above)
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Baseline and post-intervention (approximately 8 weeks)
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Insomnia Severity Index
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
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 and post-intervention (approximately 8 weeks)
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Self-Efficacy for Exercise (SEE) Scale
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
The Self-Efficacy for Exercise (SEE) scale is a questionnaire designed to measure an individual's confidence in their ability to exercise regularly.
Participants rate their confidence on a scale, often from 0 (not at all confident) to 10 (very confident).
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Baseline and post-intervention (approximately 8 weeks)
|
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Short Acculturation Scale for Hispanics (SASH)
Time Frame: Baseline
|
The Short Acculturation Scale for Hispanics is a 12-item questionnaire developed to measure the degree of acculturation experienced by Hispanics in the United States.
Scores range from 1 to 5, where higher scores indicate a greater level of acculturation to mainstream U.S. culture.
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Baseline
|
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Discrimination in Medical Settings Scale
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
The Discrimination in Medical Settings (DMS) scale is a 7-item questionnaire that measures patient-reported experiences of mistreatment in healthcare settings.
It uses a 5-point Likert scale for each item, asking patients how often they have experienced specific scenarios, such as being treated with less courtesy or feeling a doctor is not listening to them.
Higher scores on the scale indicate more frequent experiences of discrimination, and it is used to study disparities in healthcare.
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Baseline and post-intervention (approximately 8 weeks)
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Brief Pain Inventory (BPI)
Time Frame: Baseline and post-intervention (approximately 8 weeks)
|
The Brief Pain Inventory (BPI) is a 9-item self-report tool that measures pain severity and how pain interferes with daily activities on a 0-10 scale, with higher scores indicating greater pain.
It shows excellent reliability, with Cronbach's alpha typically between 0.80 and 0.95.
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Baseline and post-intervention (approximately 8 weeks)
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Leisure Time Exercise Questionnaire of Godin and Shephard
Time Frame: Baseline and post-intervention (approximately 8 weeks)
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The Leisure-Time Exercise Questionnaire (LTEQ) by Godin and Shephard is a brief self-report measure that asks about the frequency of mild, moderate, and strenuous exercise during a typical week.
Responses are converted into a weekly leisure activity score by weighting each intensity level.
The LTEQ demonstrates good reliability, with Cronbach's alpha values around 0.80 and strong test-retest stability.
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Baseline and post-intervention (approximately 8 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Evelyn Arana, DrPH, Rutgers Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2025000098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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