Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Self Reported Behavioral Automaticity Index
研究概览
简要总结
Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition.
To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.
详细描述
The objective of the present study is to determine the feasibility of a manual, theory based, occupational therapist delivered, preventative intervention to increase habit development (HD) of healthy dietary and physical activity behaviors, and reduce metabolic syndrome (MetS) among high-risk, rural breast cancer survivors (BCS). Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural BCS (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit telephone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs. Feasibility metrics will be collected throughout the intervention. The one specific aim is:
Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Diagnosis of stage 1-3 histologically confirmed first cancer of the breast
- •Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service
- •Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:
- •A large waistline > 35 inches Blood pressure > 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels > 150 mg/dL; HDL cholesterol levels < 50 mg/dL
排除标准
- •Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS
- •Pregnant patients
- •Resistant Hypertension
- •Steroid-dependent asthma or Chronic obstructive pulmonary disease
- •Cirrhosis or hepatic failure
- •A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days
- •Chronic kidney disease on renal replacement therapy
- •Type one or two diabetes
- •Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)
- •Taking weight loss medications
- •Current involvement in a behavioral program
- •Neuropsychiatric disorder or dementia
结局指标
主要结局
Self Reported Behavioral Automaticity Index
时间窗: From week 0-2
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
次要结局
未报告次要终点
研究者
Heather Fritz
Principal Investigator
Barbara Ann Karmanos Cancer Institute