Stay on Track: A Study of Exercise Effects During Radiation
NCT ID: NCT03243786
Last Updated: 2021-11-30
Study Results
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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COMPLETED
NA
47 participants
INTERVENTIONAL
2017-04-12
2018-10-31
Brief Summary
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Detailed Description
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Procedure Summary. Patients who are eligible are consented by the research coordinator, after which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and phlebotomy. Participants will also wear the Fitbit for one week to establish baseline activity level. After the baseline assessment, women are then randomly assigned to: the 12-week "Stay on Track" lifestyle intervention or the 12-week self-guided control. Both groups complete a post-intervention and a 3-month follow-up visit identical to their baseline assessment. Self-guided controls can utilize their Fitbit and will receive informative binders 24 weeks' post-intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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12-week "Stay on Track" intervention
The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging
Lifestyle- Supportive Care
The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
12-week self-guided control
The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
Lifestyle- Supportive Care
The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
Interventions
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Lifestyle- Supportive Care
The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
Eligibility Criteria
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Inclusion Criteria
2. confirmed primary non-metastatic breast adenocarcinoma;
3. planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
4. planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
5. Have a Karnovsky Performance Score of 70 or above (see Appendix)
6. Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
7. have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
8. understand and speak English;
9. physically able to engage in the intervention;
10. accepting of randomization (Note that anti-estrogen therapy is allowed.)
Exclusion Criteria
2. Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
3. Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
4. Patients who have received chemotherapy for their breast cancer.
5. Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
18 Years
FEMALE
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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John Longo
Assistant Professor Radiation Oncology
Principal Investigators
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Carmen Bergom, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PRO00027661
Identifier Type: -
Identifier Source: org_study_id