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

Primary Purpose

Breast Cancer Female, Survivorship

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional and goal-setting education, yoga
Sponsored by
Mount Mary University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Mary University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition, goal-setting, yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in central adiposity
circumferential measurement of waist

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2018
Last Updated
June 28, 2018
Sponsor
Mount Mary University
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1. Study Identification

Unique Protocol Identification Number
NCT03575624
Brief Title
Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors
Official Title
Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Mary University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Survivorship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single arm model.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition, goal-setting, yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional and goal-setting education, yoga
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in central adiposity
Description
circumferential measurement of waist
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Independent yoga posture series
Description
participant independently demonstrates series of 6 postures
Time Frame
20 weeks
Title
Change in body weight
Description
weight in pounds
Time Frame
20 weeks
Title
Change in balance
Description
Time in seconds in single-leg stance
Time Frame
20 weeks
Title
independent healthy meal preparation
Description
participant brings dish prepared from intervention recipe focusing on nutrition
Time Frame
Post intervention, after 20 weeks
Title
Goal setting
Description
Participant independently writes SMART (specific, measureable,attainable , reasonable, timely)
Time Frame
20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie H Hunley, PhD
Organizational Affiliation
Mount Mary University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Mary University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27057575
Citation
Beyer KM, Zhou Y, Matthews K, Hoormann K, Bemanian A, Laud PW, Nattinger AB. Breast and Colorectal Cancer Survival Disparities in Southeastern Wisconsin. WMJ. 2016 Feb;115(1):17-21.
Results Reference
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PubMed Identifier
23668396
Citation
Garg SK, Maurer H, Reed K, Selagamsetty R. Diabetes and cancer: two diseases with obesity as a common risk factor. Diabetes Obes Metab. 2014 Feb;16(2):97-110. doi: 10.1111/dom.12124. Epub 2013 Jun 12.
Results Reference
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Citation
NCHS, National Health Interview Survey, 2016, Sample Adult Core component retrieved online https://www.cdc.gov/nchs/data/nhis/earlyrelease/EarlyRelease201803_07.pdf
Results Reference
background
PubMed Identifier
17785709
Citation
Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
Results Reference
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Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors

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