The Preoperative Health & Body Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Group

Supervised exercise sessions and independent exercise

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Supervised exercise sessions and independent exercise

Mind-Body Group

Surgical preparation program

Group Type ACTIVE_COMPARATOR

Surgical preparation program

Intervention Type BEHAVIORAL

Book, tapes, CD

Interventions

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Exercise

Supervised exercise sessions and independent exercise

Intervention Type BEHAVIORAL

Surgical preparation program

Book, tapes, CD

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No