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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
| University of Massachusetts, Worcester | OTHER |
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The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.
This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.
Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.
Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss & Exercise | Experimental | Single arm intervention of a 24 week weight loss and exercise intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss and Exercise | Behavioral | Internet delivered, behaviorally based weight loss and exercise intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study. | Change from baseline fesability at 6 months |
| Change in diet measures | Efficacy will be measured using total calories and fat grams before and after the intervention | Change from baseline diet measures at 6 months |
| Change in anthropometric measures | Change in Weight, BMI, body fat percentage before and after the intervention | Change from baseline anthropometrics at 6 months |
| Change in active energy expenditure (ie exercise) | exercise will be measured using an accelerometer before and after the intervention | Change from baseline active energy expenditure at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory biomarkers | Change in Il-6, hsCRP before and after the intervention | Change from baseline inflammatory biomarkers at 6 months |
| Change in insulin resistance markers | Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim L Dittus, MD PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States | ||
| Dartmouth Hitchcock Medical Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Change from baseline insulin resistance markers at 6 months |
| Hannover |
| New Hampshire |
| 03755 |
| United States |
| Unviersity of Vermont/Fletcher Allen Health Care | Burlington | Vermont | 05405 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |