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
About this trial
This is an interventional treatment trial for Breast Cancer Female
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
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
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
background
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
background
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
background
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Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors
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