Being Well, Staying Healthy: An Integrated Mind-Body Medicine Intervention to Decrease Fatigue Among Breast Cancer Survivors, PILOT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- change in fatigue score
研究概览
简要总结
This research project is being done to design and then test whether a 10 week program can help reduce the symptoms of being tired and fatigued among women who have had breast cancer. The pilot study will include 4 groups of women, two groups of women from Baltimore and two groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The purpose of this pilot study is to help us find the best things to include in the program to help women who have had breast cancer and who have severe problems with fatigue that has lasted months to years after being treated with chemotherapy or radiation therapy.
Following the pilot program we will conduct and evaluate (using a quasi-experimental design comparing fatigue scores before and after the intervention) the efficacy of the refined 10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast cancer survivors who have completed their adjuvant therapy. Four intervention groups (~12 women per group) will be conducted: two in the urban setting and two in the rural setting. We will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6 months following completion of the program. We will compare mean baseline scores to post-intervention scores.
The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for improving symptoms of fatigue and thus improving quality of life among breast cancer survivors
详细描述
Research Question:
Fatigue is a common, persistent symptom following treatment for breast cancer, challenging a women's ability to promptly regain her overall health and well-being. The aim of the study is to design, evaluate and implement an integrated mind-body medicine intervention to reduce symptoms of persistent fatigue.
The research questions being addressed are: Can a 10 week mind-body medicine intervention program improve fatigue scores from the disability range to the non-disabled range and does the improvement in fatigue symptoms persist up to 6 months following the intervention?
The aims of the study are to Aim I: Pilot test a 10 week mind/body medicine group intervention among 4 groups of breast cancer survivors with 5 women per group. Groups will be stratified by urban/rural setting (Baltimore region/Washington County), race (African American and White), and educational status. These pilot groups will evaluate the program to help refine the intervention to be comprehensible and culturally sensitive.
Aim II: A 10-week intervention program will be developed specifically targeted to alleviate fatigue among breast cancer survivors. Weekly sessions of approximately 2 hours duration will be held. Four intervention groups with approximatley 12 women per group women will be conducted in two regions, an urban setting and a rural setting. The interventions will be conducted at the Women's Center for Health & Medicine at the Mercy Medical Center in downtown Baltimore and the Robinwood Outpatient Medical Facility in Hagerstown Maryland (Washington County.) The Women's center is located downtown Baltimore with access to public transportation as well as a having convenient parking with valet services. The Robinwood Center is also centrally located in Washington County near Hagerstown, MD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe fatigue >6 months after last chemotherapy or radiation treatment >5 years from diagnosis
排除标准
- •Metastatic disease-
结局指标
主要结局
change in fatigue score
次要结局
未报告次要终点