NCT06844981

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 28, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

January 28, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

CancerCancer SurvivorshipSleep DisturbancesHispanic Cancer SurvivorsLatin Dancing

Outcome Measures

Primary Outcomes (3)

  • Feasibility of the Intervention

    Feasibility in this study will include recruitment, adherence, and retention rates.

    8 weeks

  • Treatment Perception Questionnaire (Acceptability of Intervention)

    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.

    Post-intervention (at approximately 8 weeks)

  • Pittsburgh Sleep Quality Index

    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.

    Baseline and post-intervention (approximately 8 weeks)

Secondary Outcomes (17)

  • 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)

  • +12 more secondary outcomes

Study Arms (2)

Usual care arm

NO INTERVENTION

Participants in the usual care arm will receive care as usual and will not participate in the Latin Dancing program.

Intervention arm

EXPERIMENTAL

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.

Behavioral: Latin Dance

Interventions

Latin DanceBEHAVIORAL

Latin Dance intervention

Also known as: intervention arm
Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

ParasomniasNeoplasms

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Evelyn Arana, DrPH

    Rutgers Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Arana, DrPH

CONTACT

Arlette Chavez, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 25, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations