Clinical trial NCT03719677: Reducing Metabolic Syndrome Among Breast Cancer Survivors
Official title: Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 7
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Primary outcomes:
measure: Self Reported Behavioral Automaticity Index
timeFrame: From week 0-2
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Wayne State University
name: Heather Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References: