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The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.
Research Design. The investigators will be conducting an randomized trial in 60 women undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week lifestyle intervention that addresses diet and physical activity and to explore the impact on behavioral, biological and psychosocial outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-week "Stay on Track" intervention | Active Comparator | 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 |
|
| 12-week self-guided control | Active Comparator | The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle- Supportive Care | Behavioral | The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participant retention thoughout the 12-week intervention through the six month follow-up | 6 months | |
| The percent of eligible patient who choose to take part in the study | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
Female Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Bergom, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm |
| 6 months |
| Changes in lean soft tissue over the study period associated with intervention and activity | 6 months |
| Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity | 6 months |
| Measures of physical activity (self-report and objective) | 6 months |
| Dietary intake (assessed via Full Length Block Questionnaire) | 6 months |
| Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring) | 6 months |
| Measures of skin side effects (CTCAE v4.0 Scoring) | 6 months |
| Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity | 6 months |
| Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity | 6 months |
| Changes in biomarker (GM-CSF) associated with intervention and activity | 6 months |
| Changes in biomarker (IFN-gamma) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-1alpha) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-1beta) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-4) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-6) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-8) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-10) associated with intervention and activity | 6 months |
| Changes in biomarker (IL-12) associated with intervention and activity | 6 months |
| Changes in biomarker (MCP-1) associated with intervention and activity | 6 months |
| Changes in biomarker (TNF-alpha) associated with intervention and activity | 6 months |
| Changes in biomarker (adiponectin) associated with intervention and activity | 6 months |
| Changes in biomarker (leptin) associated with intervention and activity | 6 months |
| Changes in biomarker (CRP) associated with intervention and activity | 6 months |
| Changes in blood insulin level associated with intervention and activity | 6 months |
| Changes in blood hemoglobin A1C level associated with intervention and activity | 6 months |
| Changes in blood glucose level associated with intervention and activity | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |