A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Quality of life(QoL)
研究概览
简要总结
This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.
III. To provide a preliminary test of its efficacy.
OUTLINE:
Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
- •English speaking
- •Able and willing to give informed consent
- •To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:
- •Diagnosis of recurrent breast or ovarian cancer with any disease-free interval
排除标准
- •Residence > 70 miles from research site
- •Subnormal intellectual potential (diagnosis of mental retardation)
- •Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
- •Non-ambulatory
- •Life expectancy less than 160 days, per the treating oncologist
- •Current suicide risk sufficient to preclude treatment on an outpatient basis
- •Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)
结局指标
主要结局
Quality of life(QoL)
时间窗: up to 28 weeks
Quality of life as assessed by Short Form (SF)-36
次要结局
- Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)(Up to 28 weeks)
- Fatigue as assessed by the Fatigue Severity Index (FSI)(Up to 28 weeks)
- Diurnal cortisol slope(Up to 28 weeks)
- Stress as assessed by the Impact of Event Scale (IES)(Up to 28 weeks)
- Inflammation(Up to 28 weeks)
- Mood as assessed by the Profile of Mood States (POMS)(Up to 28 weeks)
- Pain as assessed by the Brief Pain Inventory (BPI)(Up to 28 weeks)
研究者
Barbara Andersen
Principal Investigator
Ohio State University Comprehensive Cancer Center