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| ID | Type | Description | Link |
|---|---|---|---|
| SHU-USMS-DEBRA | |||
| ISRCTN08045231 | |||
| EU-20821 |
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RATIONALE: Studying diet and exercise interventions in overweight and obese patients with breast cancer may help doctors learn more about how to help patients lose weight and change their body composition.
PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it works compared with normal care in overweight or obese women who have undergone treatment for stage I, stage II, or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to one of intervention arms.
Patients are also given individualized healthy-eating dietary advice and written information packet named ' Weight Loss On A Plate'. Patients are also counseled on how to reduce their dietary fat intake to 25% of total caloric intake, eating at least 5 portions of fruit and vegetables daily, increasing fiber intake, reducing carbohydrates, and taking moderate amounts of alcohol. Patients are also counseled on how to reduce their total daily calorie intake to 600 kcal below their calculated energy requirements. Individual energy requirements will be estimated from a formula of basal metabolic rate and physical activity level. Patients complete a 3-day diet diary prior to beginning study treatment and then weekly throughout the study. The diaries from pre-intervention and from weeks 6, 12, 18, and 24 are analyzed, looking specifically at macronutrients. Patients meet with the research assistant once weekly to discuss their individual diet diaries and identify ways in which they can further improve their nutritional intake.
Depression, psychological stress, and quality of life are assessed at baseline and then at 12 weeks, and 25 weeks.
Blood samples are examined for various biomarkers including interleukin-6 by ELISA, estradiol by radioimmunoassay, and for lymphocyte phenotyping and NK-cell activity by flow cytometry.
Salivary cortisol levels are measured 4 times on two consecutive days by high-sensitivity salivary cortisol enzyme immunoassay.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral dietary intervention | Behavioral | |||
| exercise intervention | Behavioral | |||
| counseling intervention | Other | |||
| flow cytometry | Other | |||
| immunoenzyme technique | Other | |||
| laboratory biomarker analysis | Other | |||
| complementary or alternative medicine procedure | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | ||
| Body composition |
| Measure | Description | Time Frame |
|---|---|---|
| Pychological stress via the Perceived Stress Scale | ||
| Depression via the Beck Depression Inventory II | ||
| Cardiorespiratory fitness |
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DISEASE CHARACTERISTICS:
Diagnosis of stage I, II, or III breast cancer
Body mass index (BMI) > 25
Patients must have completed treatment for breast cancer within the past 3-18 months
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John M. Saxton, PhD | Royal Hallamshire Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Hallam University - City Campus | Sheffield | England | S1O 2JF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16469108 | Result | Saxton JM, Daley A, Woodroofe N, Coleman R, Powers H, Mutrie N, Siddall V, Crank H. Study protocol to investigate the effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment [ISRCTN08045231]. BMC Cancer. 2006 Feb 9;6:35. doi: 10.1186/1471-2407-6-35. |
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| standard follow-up care | Procedure |
| Quality of life via the FACT-G and FACT-B |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D005434 | Flow Cytometry |
| D007124 | Immunoenzyme Techniques |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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