N/A N=7 Prevention

Reducing Metabolic Syndrome Among Breast Cancer Survivors

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03719677 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Self Reported Behavioral Automaticity Index — 1.6; 4.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Habit development intervention (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Barbara Ann Karmanos Cancer Institute
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Self Reported Behavioral Automaticity Index	1.6; 4.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03719677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.