Clinical trial NCT06844981: Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
Official title: Moviendo Las Caderas: Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivorship
Sleep Disturbances
Keywords: Cancer
Cancer Survivorship
Sleep Disturbances
Hispanic Cancer Survivors
Latin Dancing
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 8 weeks
measure: Treatment Perception Questionnaire (Acceptability of Intervention)
timeFrame: Post-intervention (at approximately 8 weeks)
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and post-intervention (approximately 8 weeks)
Secondary outcomes:
measure: Functional Outcomes for Cancer Therapy - General
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Functional Assessment of Chronic Illness - Fatigue
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Brief Symptom Inventory - 18
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Insomnia Severity Index
timeFrame: 8 weeks
measure: Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
timeFrame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
measure: Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy
timeFrame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
measure: Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
timeFrame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
measure: Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy
timeFrame: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
measure: Charleson Comorbidity Index
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Physical Activity Daily Diaries
timeFrame: Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
measure: Sleep Daily Diaries
timeFrame: Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute
name: Evelyn Arana, DrPH
role: PRINCIPAL_INVESTIGATOR
References: