Clinical Trials Directory

Trials / Completed

CompletedNCT03262831

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERYogaThe 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
PROCEDUREBlood draw* Baseline and end of treatment * To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
BEHAVIORALFACT-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
PROCEDUREWeight measurement-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
BEHAVIORALRecent Physical Activity Questionnaire-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
BEHAVIORALNHANES Food Questionnaire-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Timeline

Start date
2018-01-10
Primary completion
2019-06-26
Completion
2019-06-26
First posted
2017-08-25
Last updated
2019-09-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03262831. Inclusion in this directory is not an endorsement.