Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Latin Dance
BehavioralLatin Dance intervention
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Usual care armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the Intervention
Feasibility in this study will include recruitment, adherence, and retention rates.
Time frame
8 weeks2
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.
Time frame
Post-intervention (at approximately 8 weeks)3
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.
Time frame
Baseline and post-intervention (approximately 8 weeks)Secondary outcomes
1
Functional Outcomes for Cancer Therapy - General
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)2
Functional Assessment of Chronic Illness - Fatigue
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)3
Patient Health Questionnaire - 2 (PHQ-2)
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)4
Generalized Anxiety Disorder - 7 (GAD-7)
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)Sponsors and contacts
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Source ClinicalTrials.gov