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

Washington University School of Medicine30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Cancer of Breast

Interventions

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

Blood drawPROCEDURE

* Baseline and end of treatment * To evaluate change in inflammatory markers (CRP, IL-6, and TNF)

FACT-G questionnaireBEHAVIORAL

* 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

Weight measurementPROCEDURE

-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment

Recent Physical Activity QuestionnaireBEHAVIORAL

-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.

NHANES Food QuestionnaireBEHAVIORAL

-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Completion of study enrollment (estimated to be 6 months)

Efficacy of yoga exercise as measured by weight change from baseline to completion