Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors

June 28, 2018 updated by: Mount Mary University
The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Social and environmental issues continue to impact disease morbidity and mortality resulting in the inequities of health, wellness, and quality of life experienced by African American breast cancer survivors (AABCS) living in urban Milwaukee. AABCS outcomes in Milwaukee are significantly worse (OR=1.55) than those of Caucasian survivors.

The American Diabetes Association/American Cancer Society expert committee recommends the promotion of a healthy diet, physical activity, and weight management with low waist circumference to prevent diabetes, cancer, and obesity and to extend life expectancy. According to the National Health Interview Survey, 56% of African Americans are inactive. Yoga is one way to increase physical activity while improving wellness and health in AABCS.

The investigator's goal was to facilitate improved self-care efficacy through evidence-based integrative health and wellness strategies to help families overcome the effects of multiple negative, deep-rooted social determinants.

Study Type

Interventional

Enrollment (Actual)

17

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
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53222
        • Mount Mary University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Sex: female
  • Race: African American
  • Survivor of breast cancer
  • Physical activity participation not limited by medical doctor
  • English speaking

Exclusion Criteria:

  • Sex: male
  • Race: not African American
  • No breast cancer history
  • Physical activity limitations imposed by medical doctor

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition, goal-setting, yoga
Behavioral: Nutritional and goal-setting education, yoga to promote achievement of change in health behaviors. SMART goal setting was used to guide nutritional and physical activity change to decrease disease risk and promote well-being.
Behavioral: Nutritional and goal-setting education, yoga

This integrative program series, Live Well, was delivered bi-weekly from January-May 2017, by an interdisciplinary team of a registered nurse, occupational therapist/researcher, registered dietitian, and certified yoga instructor.

Session experiences were designed to build:

Sisterhood for health promotion and support, Individual and group health promotion through goal-setting, Healthy family nutrition and meal planning skills , Family integrated yoga practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in central adiposity
Time Frame: 20 weeks
circumferential measurement of waist
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent yoga posture series
Time Frame: 20 weeks
participant independently demonstrates series of 6 postures
20 weeks
Change in body weight
Time Frame: 20 weeks
weight in pounds
20 weeks
Change in balance
Time Frame: 20 weeks
Time in seconds in single-leg stance
20 weeks
independent healthy meal preparation
Time Frame: Post intervention, after 20 weeks
participant brings dish prepared from intervention recipe focusing on nutrition
Post intervention, after 20 weeks
Goal setting
Time Frame: 20 weeks
Participant independently writes SMART (specific, measureable,attainable , reasonable, timely)
20 weeks

Collaborators and Investigators

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

Sponsor

Mount Mary University

Investigators

  • Principal Investigator: Julie H Hunley, PhD, Mount Mary University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 26, 2017

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170126

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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