이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

히스패닉 암 생존자의 수면 품질에 대한 라틴 춤의 영향

2026년 11월 10일 업데이트: Evelyn Arana, DrPH, Rutgers, The State University of New Jersey

Moviendo Las Caderas : 히스패닉 암 생존자의 수면 품질에 대한 라틴 춤의 영향

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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • New Jersey
      • New Brunswick, New Jersey, 미국, 08901
        • 모병
        • Rutgers Cancer Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Usual care arm

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

실험적: Intervention arm

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.

Latin Dance intervention

다른 이름들:
  • 중재 팔

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the Intervention
기간: 8 weeks

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

8 weeks
Treatment Perception Questionnaire (Acceptability of Intervention)
기간: 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.

Post-intervention (at approximately 8 weeks)
Pittsburgh Sleep Quality Index
기간: 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.

Baseline and post-intervention (approximately 8 weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Outcomes for Cancer Therapy - General
기간: 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.

Baseline and post-intervention (approximately 8 weeks)
Functional Assessment of Chronic Illness - Fatigue
기간: 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).

Baseline and post-intervention (approximately 8 weeks)
Patient Health Questionnaire - 2 (PHQ-2)
기간: Baseline and post-intervention (approximately 8 weeks)

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)
기간: Baseline and post-intervention (approximately 8 weeks)

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
기간: Baseline and post-intervention (approximately 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.

Baseline and post-intervention (approximately 8 weeks)
Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
기간: 2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)

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
기간: 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.

2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
기간: 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.

2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy
기간: 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.

2 weeks (worn for 1 week at Baseline and 1 week at post-intervention)
Charleson Comorbidity Index
기간: 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.

Baseline and post-intervention (approximately 8 weeks)
Physical Activity Daily Diaries
기간: 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.

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
기간: 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.

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
기간: Baseline and post-intervention (approximately 8 weeks)

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)
기간: Baseline

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
기간: Baseline and post-intervention (approximately 8 weeks)

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)
기간: Baseline and post-intervention (approximately 8 weeks)

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
기간: Baseline and post-intervention (approximately 8 weeks)

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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Evelyn Arana, DrPH, Rutgers Cancer Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2025년 1월 28일

QC 기준을 충족하는 최초 제출

2025년 2월 21일

처음 게시됨 (실제)

2025년 2월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 10일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Pro2025000098

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .