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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03575624
Other study ID # 20170126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2017
Est. completion date June 15, 2017

Study information

Verified date June 2018
Source Mount Mary University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date June 15, 2017
Est. primary completion date June 15, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Mount Mary University Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Mount Mary University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View 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. Epub 2007 Sep 4. — View Citation

NCHS, National Health Interview Survey, 2016, Sample Adult Core component retrieved online https://www.cdc.gov/nchs/data/nhis/earlyrelease/EarlyRelease201803_07.pdf

Outcome

Type Measure Description Time frame Safety issue
Primary Change in central adiposity circumferential measurement of waist 20 weeks
Secondary Independent yoga posture series participant independently demonstrates series of 6 postures 20 weeks
Secondary Change in body weight weight in pounds 20 weeks
Secondary Change in balance Time in seconds in single-leg stance 20 weeks
Secondary independent healthy meal preparation participant brings dish prepared from intervention recipe focusing on nutrition Post intervention, after 20 weeks
Secondary Goal setting Participant independently writes SMART (specific, measureable,attainable , reasonable, timely) 20 weeks
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