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The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survivors RESET intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survivors RESET | Behavioral | 16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Percentage of participants who are contacted and enroll in the study. | Baseline |
| Retention Rate | Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4). | Baseline to Month 4 |
| Adherence | Adherence will be assessed by the number of treatment sessions attended. | Baseline to Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 4-month mean change in weight | Weight change as measured by a SECA scale in kilograms at baseline and month 4 will be calculated and averaged | Baseline to Month 4 |
| 4-month mean change in allostatic load score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Carson, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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Allostatic load score will be calculated using a validated equation. Change from baseline to month 4 will be calculated and averaged.
| Baseline to Month 4 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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