Reducing Metabolic Syndrome Among Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719677
• Other study ID #: 2018-062
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: September 13, 2020

Study information

• Verified date: October 2020
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 13, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metabolic Syndrome

Intervention

Behavioral:
• Habit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported Behavioral Automaticity Index	Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit	From week 0-2