NCT02351479已完成不适用
Hula, a Physical Activity Intervention for Female-Cancer Survivors
University of Hawaii1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Hula Program Feasibility (Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention)
研究概览
简要总结
A six-month interventional program to determine the biological and psychosocial effects of hula as a form of physical activity for female breast, cervical, endometrial or ovarian cancer survivors living on Oahu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Lives on Oahu
- •Diagnosed with primary breast,cervical, endometrial or ovarian cancer (stage I-III)
- •Completed initial regional and systemic treatment for breast cancer 2 months ago
- •Physically capable of doing the hula-based physical activity
- •Receives approval by attending physician to participate in trial
排除标准
- •Currently undergoing chemotherapy or radiation therapy
研究组 & 干预措施
Hula
Other
Hula is an ancient, Native Hawaiian dance form of cultural expression and physical activity. Participants will attend one-hour hula classes twice a week for six months.
干预措施: Hula (Behavioral)
结局指标
主要结局
Hula Program Feasibility (Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention)
时间窗: 6 months after the start of the intervention program
Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention
次要结局
- Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Demographics (Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Health-Related Quality of Life (Quality of life of participants assessed using The European Organization for Research and Treatment of Cancer QLQ-C30.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)(Baseline, 6 months and 12 months after the start of the intervention program)
- DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)(Baseline, 6 months and 12 months after the start of the intervention program)
- Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)(Baseline, 6 months and 12 months after the start of the intervention program)
- Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)(Baseline, 6 months and 12 months after the start of the intervention program)
研究者
研究点 (1)
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