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

Not Applicable

Completed

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

• Registration Number: NCT03262831
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2018-01-10
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: No Yoga	NHANES Food Questionnaire	-Patients in this arm will not receive a personalized yoga plan
Arm 1: Yoga	FACT-G questionnaire	* 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.
Arm 1: Yoga	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.
Arm 2: No Yoga	Weight measurement	-Patients in this arm will not receive a personalized yoga plan
Arm 2: No Yoga	Recent Physical Activity Questionnaire	-Patients in this arm will not receive a personalized yoga plan
Arm 1: Yoga	Blood draw	* 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.
Arm 1: Yoga	Recent Physical Activity Questionnaire	* 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.
Arm 2: No Yoga	FACT-G questionnaire	-Patients in this arm will not receive a personalized yoga plan
Arm 1: Yoga	Weight measurement	* 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.
Arm 2: No Yoga	Blood draw	-Patients in this arm will not receive a personalized yoga plan
Arm 1: Yoga	NHANES Food Questionnaire	* 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of yoga exercise as measured by inflammatory markers	Completion of treatment (estimated to be 6 months)
Effect of yoga exercise as measured by quality of life	Completion of treatment (estimated to be 6 months)	-Quality of life will be measured by FACT-G questionnaire
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 fatigue index	Completion of treatment (estimated to be 6 months)	-Fatigue index will be measured by FACT-G questionnaire

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States