NCT03575845

Brief Summary

The purpose of this study was to determine if occupational therapy informed yoga could decrease barriers to occupational engagement in African American breast cancer survivors. .

Trial Health

100
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 Jun 2015

Shorter than P25 for not_applicable

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

June 5, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

June 17, 2018

Last Update Submit

June 29, 2018

Conditions

Breast Neoplasm Female

Keywords

Yoga

Outcome Measures

Primary Outcomes (1)

  • Change in dynamic balance

    Dynamic balance measured with Functional Reach Assessment

    Week 1 & week 6

Secondary Outcomes (2)

  • Change in Pain

    Week 1 & week 6

  • Change in Mental Health

    Week 1 & week 6

Study Arms (1)

Occupational therapy informed yoga

EXPERIMENTAL

Occupational therapists adapted postures to meet the abilities and rehabilitation needs of individual breast cancer survivors engaging in group-delivered yoga sessions

Behavioral: Occupational Therapy Informed Yoga

Interventions

Occupational Therapy Informed YogaBEHAVIORAL

Occupational therapy informed yoga met weekly for six, 60-minute sessions. Each session started with a seated warm-up to coordinate breath and movement and promote upper extremity mobility. Standing postures followed to target balance. Sessions closed with restorative postures in seated and supine variations.

Occupational therapy informed yoga

Eligibility Criteria

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

You may qualify if:

  • African American race
  • Breast Cancer survivor
  • No medical restrictions on activity

You may not qualify if:

  • Race other than African American
  • No history of breast cancer
  • Medical restrictions on activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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

  • Taylor TR, Barrow J, Makambi K, Sheppard V, Wallington SF, Martin C, Greene D, Yeruva SLH, Horton S. A Restorative Yoga Intervention for African-American Breast Cancer Survivors: a Pilot Study. J Racial Ethn Health Disparities. 2018 Feb;5(1):62-72. doi: 10.1007/s40615-017-0342-4. Epub 2017 Apr 14.

    PMID: 28411330BACKGROUND

  • Daly B, Olopade OI. A perfect storm: How tumor biology, genomics, and health care delivery patterns collide to create a racial survival disparity in breast cancer and proposed interventions for change. CA Cancer J Clin. 2015 May-Jun;65(3):221-38. doi: 10.3322/caac.21271. Epub 2015 Apr 9.

    PMID: 25960198BACKGROUND

  • Coughlin SS, Yoo W, Whitehead MS, Smith SA. Advancing breast cancer survivorship among African-American women. Breast Cancer Res Treat. 2015 Sep;153(2):253-61. doi: 10.1007/s10549-015-3548-3. Epub 2015 Aug 25.

    PMID: 26303657BACKGROUND

  • Mollica M, Newman SD. Breast cancer in African Americans: from patient to survivor. J Transcult Nurs. 2014 Oct;25(4):334-40. doi: 10.1177/1043659614524248. Epub 2014 Mar 4.

    PMID: 24595162BACKGROUND

  • Bower JE, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Greendale G. Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial. Cancer. 2012 Aug 1;118(15):3766-75. doi: 10.1002/cncr.26702. Epub 2011 Dec 16.

    PMID: 22180393BACKGROUND

  • Harder H, Parlour L, Jenkins V. Randomised controlled trials of yoga interventions for women with breast cancer: a systematic literature review. Support Care Cancer. 2012 Dec;20(12):3055-64. doi: 10.1007/s00520-012-1611-8. Epub 2012 Oct 6.

    PMID: 23052917BACKGROUND

  • Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.

    PMID: 21207071BACKGROUND

  • Levine AS, Balk JL. Yoga and quality-of-life improvement in patients with breast cancer: a literature review. Int J Yoga Therap. 2012;(22):95-9.

    PMID: 23070679BACKGROUND

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: single arm pretest-posttest design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2018

First Posted

July 3, 2018

Study Start

June 5, 2015

Primary Completion

July 16, 2015

Study Completion

October 24, 2015

Last Updated

July 3, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share