Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
Location status: Recruiting
NCT Number: NCT06844981
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Brunswick, New Jersey, 08901, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Latin Dance intervention
Other names: intervention arm
Time frame: 8 weeks
Feasibility in this study will include recruitment, adherence, and retention rates.
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.
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.
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.
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).
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.
Time frame: Baseline and post-intervention (approximately 8 weeks)
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)
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.
Time frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Actigraphy will measure the number of minutes of actual sleep.
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.
Time frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
Time frame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Actigraphy will measure the minutes it takes for the participant to fall asleep.
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.
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.
The physical activity daily diary is designed to gather information about participants' daily physical activity patterns.
Time frame: Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
The sleep diary is designed to gather information about participants' daily sleep patterns.
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).
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.
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.
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.
Time frame: Baseline and post-intervention (approximately 8 weeks)
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.
Contact information is provided by the study sponsor or research team.
Arlette Chavez, MD
CONTACT
Evelyn Arana, DrPH
CONTACT
Rutgers, The State University of New Jersey
Other
Moviendo Las Caderas: Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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