Reducing Metabolic Syndrome Among Breast Cancer Survivors
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03719677
- Run by
- Barbara Ann Karmanos Cancer Institute
- People needed
- 7
- Starts
- 2018-11-06
- Expected to finish
- 2020-09-13
- Last updated by the study team
- 2020-11-20
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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