Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latin Dance | Behavioral | Latin Dance intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Arana, DrPH | Contact | 908-642-0861 | earana@CINJ.Rutgers.edu | |
| Arlette Chavez, MD | Contact | 732-715-4923 | ac2758@CINJ.Rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evelyn Arana, DrPH | Rutgers Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08901 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and post-intervention (approximately 8 weeks) |
| 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). | Baseline and post-intervention (approximately 8 weeks) |
| 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. | Baseline and post-intervention (approximately 8 weeks) |
| 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) | Baseline and post-intervention (approximately 8 weeks) |
| Insomnia Severity Index | 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. | Baseline and post-intervention (approximately 8 weeks) |
| Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy | Actigraphy will measure the number of minutes of actual sleep. | 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention) |
| Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy | Actigraphy will measure total minutes of wake time after sleep onset. | 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention) |
| Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy | Actigraphy will measure the percent of time actually slept compared to intended time sleeping. | 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention) |
| Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy | Actigraphy will measure the minutes it takes for the participant to fall asleep. | 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention) |
| Charleson Comorbidity Index | 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. | Baseline and post-intervention (approximately 8 weeks) |
| Physical Activity Daily Diaries | The physical activity daily diary is designed to gather information about participants' daily physical activity patterns. | Physical activity daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention. |
| Sleep Daily Diaries | The sleep diary is designed to gather information about participants' daily sleep patterns. | Sleep daily diaries will be completed beginning 1 week pre-intervention, completed throughout the 8-week intervention, and 1-week post-intervention. |
| Self-Efficacy for Exercise (SEE) Scale | 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). | Baseline and post-intervention (approximately 8 weeks) |
| Short Acculturation Scale for Hispanics (SASH) | 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. | Baseline |
| Discrimination in Medical Settings Scale | 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. | Baseline and post-intervention (approximately 8 weeks) |
| Brief Pain Inventory (BPI) | 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. | Baseline and post-intervention (approximately 8 weeks) |
| Leisure Time Exercise Questionnaire of Godin and Shephard | 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. | Baseline and post-intervention (approximately 8 weeks) |