Habit Development Intervention in Improving Healthy Dietary and Physical Activity Behaviors and Reducing Metabolic Syndrome and Unmet Needs in Stages I-III Breast Cancer Survivors During the Survivorship Transition

Status: Active

Description

This trial studies how well habit development intervention works in improving healthy dietary and physical activity behaviors and reducing metabolic syndrome and unmet needs in stages I-III breast cancer survivors during the survivorship transition. The habit development intervention may help women develop healthy dietary and physical activity habits and reduce cardiovascular disease risk.

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 (USDA) 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 (> 40 inches for men and > 35 inches for women); blood pressure > 130/85; hemoglobin A1c (HbA1c) of 5.7%-6.4%; triglyceride levels > 150 mg/dL; high density lipoprotein (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 because the treatment duration and transition from primary treatment to survivorship differs from typical regimens
  • Pregnant patients
  • Those with any history of the following conditions that could prevent participation in physical activity, obscure our ability to detect changes in MetS factors, or limit participant understanding of study procedures: * Resistant hypertension (HTN) * 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

Locations & Contacts

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Heather Fritz
Phone: 313-577-9499
Email: Heather.fritz@wayne.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of a manualized, 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).

OUTLINE: Patients are randomized to 1 of 2 parts.

PART I: Patients receive a publicly available, 12 page educational pamphlet.

PART II: Patients undergo habit development intervention consisting of three face-to-face sessions, 9 tele coaching sessions, and weekly text messages over 22 weeks.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Wayne State University / Karmanos Cancer Institute

Principal Investigator
Heather Fritz

Trial IDs

Primary ID 2018-062
Secondary IDs NCI-2018-02539
Clinicaltrials.gov ID NCT03719677