Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors

Not Applicable

Not yet recruiting

• Conditions: Cancer Survivorship; Sleep Disturbances

• Registration Number: NCT06844981
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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).

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 Timeline

• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-03
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Intervention	8 weeks	Feasibility in this study will include recruitment rates and retention rates of participants
Treatment Perception Questionnaire (Acceptability of Intervention)	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	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.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Chronic Illness - Fatigue	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).
Brief Symptom Inventory - 18	Baseline and post-intervention (approximately 8 weeks)	Distress (depression and anxiety) will be measured using the Brief Symptom Inventory-18 (BSI-18). Items are summed to calculate the raw score, range 0-72. Raw scores can be converted to T-scores, based on US population norms. Participants with T-scores that are ≥ 63 are considered a "case," and may need professional help. Somatization Scale: Raw score range 0-24, with 24 indicating high somatization. Depression Scale: Raw score range 0-24, with 24 indicating high depression. Anxiety Scale: Raw score range 0-24, with 24 indicating high anxiety.
Functional Outcomes for Cancer Therapy - General	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.
Insomnia Severity Index	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.
Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy	2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)	Actigraphy will measure the number of minutes of actual sleep.
Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy	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.
Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy	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.
Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy	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.
Charleson Comorbidity Index	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.
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.	The physical activity daily diary is designed to gather information about participants' daily physical activity patterns.
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.	The sleep diary is designed to gather information about participants' daily sleep patterns.

Trial Locations

Locations (1)

Rutgers Cancer Institute; 🇺🇸 New Brunswick, New Jersey, United States