Breast Cancer Clinical Trial
The Preoperative Health & Body Study
Summary
This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. The investigators are also interested in looking at whether a short exercise or Mind-Body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development.
Since the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed, histologically confirmed stage I-III breast cancer
Planning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks.
Willing and able to participate in the intervention for at least 3 weeks prior to surgery.
ECOG performance status of 0 or 1
Approval by oncologist or surgeon
Willingness to be randomized.
English speaking and able to read English
Exclusion Criteria:
Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer)
Presence of metastatic disease
Scheduled to receive any form of neoadjuvant cancer therapy
Locally advanced breast cancer not amenable to primary surgery
History of prior ipsilateral breast cancer
Taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis
Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
Any condition which in the investigator's opinion makes the subject unsuitable for study participation
Participating in another clinical study with competing study outcomes
Pregnant (i.e., positive beta-HCG) or breast feeding
Unable to comply with protocol and/or not available for follow-up assessments
Participation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire (LSI) (Appendix I) or recent participation (past 6 months) in two or more strength training sessions per week.
Diabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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