Breast Cancer Clinical Trial
Reducing Metabolic Syndrome Among Breast Cancer Survivors
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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