A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Cancer-related fatigue (CRF)
研究概览
简要总结
The purpose of this pilot study is to examine a 12-week self-management energy conservation program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast cancer who are undergoing chemotherapy. We will also evaluate how well women like the intervention, how easy it is to use and whether women will do the activities.
详细描述
Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has explored the efficacy of energy conservation interventions for fatigue and related symptoms but no previous ECAM programs have been tested in Thailand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Thai women are age 18 or older; are diagnosed with stage I-III breast cancer; are scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals; report at least 4 out of 10 or higher on a fatigue scale in the past month; are able to read and write in Thai and can be contacted by telephone.
排除标准
- •Thai women have a history of severe psychiatric illness, or have other illnesses that could be responsible for the fatigue other than cancer such as iron deficiency anemia, multiple sclerosis, congestive heart failure, chronic fatigue syndrome or fibromyalgia. With regard to anemia, women must have a certain hemoglobin in the normal range at baseline. They also cannot have acute or chronic bone, joint, or muscular abnormalities that would increase the risk of falls and injury. Women scheduled to receive concurrent radiation therapy are not eligible.
研究组 & 干预措施
Self-management energy conservation
Thai women with breast cancer randomized to the group will receive four sessions approximately every three weeks with the PI. The women will be instructed on how to do a self-management energy conservation program.
干预措施: Self-management energy conservation (Behavioral)
Control
The participants will be given two pamphlets (general issues about breast cancer and self-care activities for patients receiving chemotherapy) provided by the health care team at the study sites. The participants in the control group will be encouraged to maintain their current daily activities during the 12-week period The participants will wear a pedometer to record the number of steps which is one of the activity outcomes.
结局指标
主要结局
Cancer-related fatigue (CRF)
时间窗: Change from baseline CRF scores at 12 weeks
A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.
次要结局
- Physical Activity (subjective measure)(Change from baseline GSLTPAG scores at 12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline HADS scores at 12 weeks)
- Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)(Change from baseline SEMCDS scores at 12 weeks)
- Physical Activity (objective measure)(Changes from baseline steps per day at 12 weeks)
- Acceptability(at 12 weeks)
- The General Sleep Disturbance (GSD)(Change from baseline GSD scores at 12 weeks)
- Fatigue Belief Questions (FBQ)(Change from baseline FBQ scores at 12 weeks)
- Satisfaction(at 12 weeks)
研究者
Wipasiri Naraphong
Postdoctoral Fellow
University of Michigan