Reducing Metabolic Syndrome Among Breast Cancer Survivors

October 29, 2020 updated by: Heather Fritz, Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Habit development intervention
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Behavioral: Habit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Reported Behavioral Automaticity Index
Time Frame: From week 0-2
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
From week 0-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Investigators

  • Principal Investigator: Heather Fritz, PhD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

September 13, 2020

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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