Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Cancer of Breast
• Intervention / Treatment: Other: Yoga; Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Eligibility Critera:

• Age ≥ 18.
• Female.
• Newly diagnosed with Stage I-III breast cancer.
• Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy.
• Not currently regularly practicing yoga (defined as at least once a month).
• Able to read and understand English
• Able to understand and willing to sign an IRB-approved written informed consent document

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1: Yoga; Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga; Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.; The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel; During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.	Other: Yoga; The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax; Procedure: Blood draw; Baseline and end of treatment; To evaluate change in inflammatory markers (CRP, IL-6, and TNF); Behavioral: FACT-G questionnaire; 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days; Answers range from 0=not at all to 4=very much; Procedure: Weight measurement; -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment; Behavioral: Recent Physical Activity Questionnaire; -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.; Other Names: RPAQ; Behavioral: NHANES Food Questionnaire; -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
ACTIVE_COMPARATOR: Arm 2: No Yoga; -Patients in this arm will not receive a personalized yoga plan	Procedure: Blood draw; Baseline and end of treatment; To evaluate change in inflammatory markers (CRP, IL-6, and TNF); Behavioral: FACT-G questionnaire; 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days; Answers range from 0=not at all to 4=very much; Procedure: Weight measurement; -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment; Behavioral: Recent Physical Activity Questionnaire; -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.; Other Names: RPAQ; Behavioral: NHANES Food Questionnaire; -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled	-Feasibility is defined as the ability to enroll 60% of eligible patients	Completion of study enrollment (estimated to be 6 months)
Feasibility of conducting a larger randomized trial using yoga and mindful movement	-Feasibility is defined as the ability to have an 80% completion rate of the intervention	Completion of study enrollment (estimated to be 6 months)
Efficacy of yoga exercise as measured by weight change from baseline to completion		Completion of treatment (estimated to be 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)		Completion of treatment (estimated to be 6 months)
Effect of yoga exercise as measured by inflammatory markers		Completion of treatment (estimated to be 6 months)
Effect of yoga exercise as measured by fatigue index	-Fatigue index will be measured by FACT-G questionnaire	Completion of treatment (estimated to be 6 months)
Effect of yoga exercise as measured by quality of life	-Quality of life will be measured by FACT-G questionnaire	Completion of treatment (estimated to be 6 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital
• Investigators: Principal Investigator: Lindsay L Peterson, M.D., MSCR, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201708076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No