Reducing Metabolic Syndrome Among Breast Cancer Survivors

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 2-arm randomized
controlled trial, 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 and preliminary effects of
the intervention 48 community-dwelling rural BCS (ages 40 and older) will be randomly
assigned to receive either the intervention or enhanced usual care. The 22-week intervention
consists of three home-based face-to-face consultations with the therapist, 10 biweekly 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 and the following behavioral and clinical outcome measures will be collected at
baseline and post intervention (week 25): habit development (operationalized as behavioral
automaticity), MetS, dietary quality, physical activity engagement, self-reported unmet
needs, and quality of life. Investigators hypothesize that the intervention will be feasible
to implement and satisfactory to participants. The one specific aim is:

Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS.
Investigators will evaluate trial randomization, recruitment, trial engagement and retention
rates, treatment satisfaction, and the feasibility of the data collection processes for the
primary behavioral measures of HD and the primary clinical measures of MetS as well as the
secondary measures of improved dietary quality, physical activity engagement, physical and
social functioning, self-reported unmet needs, and quality of life.

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