NCT03575624

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

May 10, 2018

Last Update Submit

June 28, 2018

Conditions

Breast Cancer FemaleSurvivorship

Outcome Measures

Primary Outcomes (1)

  • Change in central adiposity

    circumferential measurement of waist

    20 weeks

Secondary Outcomes (5)

  • Independent yoga posture series

    20 weeks

  • Change in body weight

    20 weeks

  • Change in balance

    20 weeks

  • independent healthy meal preparation

    Post intervention, after 20 weeks

  • Goal setting

    20 weeks

Study Arms (1)

Nutrition, goal-setting, yoga

EXPERIMENTAL

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

Interventions

Nutritional and goal-setting education, yogaBEHAVIORAL

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

Nutrition, goal-setting, yoga

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Mary University

Milwaukee, Wisconsin, 53222, United States

Location

Related 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.

    PMID: 27057575BACKGROUND

  • 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.

    PMID: 23668396BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 17785709BACKGROUND

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Julie H Hunley, PhD

    Mount Mary University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single arm model.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2018

First Posted

July 2, 2018

Study Start

January 26, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)