Developing a Health Education Intervention for Breast Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in quality of life over 6 months
研究概览
简要总结
The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
详细描述
Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
- •Having received chemotherapy as part of their primary therapy for breast cancer
- •Be in complete remission
- •Aged 18 years or older
- •Able to read, write, and understand English
- •Karnofsky Performance Status (KPS) greater than or equal to 60
- •Have impaired quality of life
- •Ability to give informed consent
排除标准
- •Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
- •Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
- •Patients on adjuvant hormone therapy for less than 2 months
- •Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
结局指标
主要结局
Change in quality of life over 6 months
时间窗: Baseline, 3 months, 6 months
The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.
次要结局
- Change in diet over 6 months(Baseline, 3 months, 6 months)
- Change in pain over 6 months(Baseline, 3 months, 6 months)
- Change in fatigue over 6 months(Baseline, 3 months, 6 months)
- Change in sleep quality over 6 months(Baseline, 3 months, 6 months)
- Change in anxiety over 6 months(Baseline, 3 months, 6 months)
- Change in depressive symptoms over 6 months(Baseline, 3 months, 6 months)