Breast CancerMyLIFENCT01630499
My Lifestyle Intervention of Food and Exercise
A study testing Tailored Lifestyle Intervention (TLI) and Commercial Weight Loss Program (CWLP) in people with Breast Cancer, run by University of Florida at 2 sites in United States.
Trial summary
Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tailored Lifestyle Intervention (TLI) and Commercial Weight Loss Program (CWLP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 21 to 65
- History of stage 1, 2, or 3 breast cancer
- Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent
- Be willing/able to attend groups and assessments in Gainesville or Jacksonville
- BMI of 27 to 45 kg/m2
- Weight-stable, i.e., not lost/gained ≥ 10 lbs in the preceding 6 months, or since the end of primary treatment
Who cannot join
- History of bariatric surgery
- Pregnant, lactating, or planning on becoming pregnant in next 12 months.
- Irritable bowel syndrome
- Serious infectious disease
- Chronic malabsorption syndrome
- Uncontrolled angina within the past 6 months
Show all 27Show fewer
- History of musculo-skeletal or chronic lung diseases that limit physical activity
- Serum creatinin > 1.5 mg/dL
- Uncontrolled or insulin-dependent diabetes (i.e., hemoglobin A1c< 10 g/dL, fasting serum triglycerides > 400 mg/dL; oral medications are not exclusionary)
- At-rest blood pressure > 140/90 mg/Hg
- Myocardial infarction
- Stroke
- Congestive heart failure
- Chronic hepatitis
- Cirrhosis
- Chronic pancreatitis
- History of solid organ transplantation
- Cancer treatment within past 5 years (other than for breast cancer)
- Any other physical condition (other than history of breast cancer) deemed likely to limit 5-year life expectancy or significantly interfere with individuals' ability to participate in a lifestyle intervention involving eating and physical activity changes.
- Use of antipsychotic medications, monoamine oxidase inhibitors, systemic corticosteroids, human immunodeficiency virus or tuberculosis antibiotics, chemotherapeutics medications, or weight-loss medications.
- Significant psychiatric disorder
- Illicit drug use or excessive use of alcohol (i.e., > 2 drinks/day)
- Currently participating in Weight Watcher's or another weight loss program
- Currently participating in another research study
- Unable to read English at the 5th grade level
- Unable/unwilling to provide informed consent
- Unwilling to receive random assignment to TLI or CWLP
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
University of North Florida
Jacksonville, Florida, 32224
About this study
Official title: Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.
- Conditions
- Breast Cancer
- Being tested
- Tailored Lifestyle Intervention (TLI), Commercial Weight Loss Program (CWLP)
- Keywords
- Cancer, Breast cancer, Breast cancer prevention, Breast cancer recurrence, Weight loss, Weight management, Overweight, Obesity
- Medical subject headings
- Breast Neoplasms, Neoplasms, Weight Loss, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Lifestyle Intervention (TLI)Behavioural
The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
Commercial Weight Loss Program (CWLP)Behavioural
This intervention is a generic, widely-available weight management program.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Lifestyle Intervention (TLI) | Experimental | Participants randomized to the TLI condition will receive a 3-month weight management program tailored to the specific needs of women in remission from breast cancer. Receives: Behavioral: Tailored Lifestyle Intervention (TLI) |
| Commercial Weight Loss Program (CLWP) | Active comparator | Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost. Receives: Behavioral: Commercial Weight Loss Program (CWLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline to post-intervention
Measured: baseline (month 0), post-intervention (month 3)
Change in body weight from post-intervention to follow-up
Measured: post-intervention (month 3), follow-up (month 9)
Secondary outcomes (31)
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention
Measured: baseline (month 0), post-intervention (month 3)
Change in HDL Cholesterol from baseline to post-intervention
Measured: baseline (month 0), post-intervention (month 3)
Change in blood glucose control from baseline to post-intervention.
HgA1c and fasting glucose to assess blood glucose control
Measured: baseline (month 0), post-intervention (month 3)
Change in caloric intake from baseline to post-intervention.
National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake.
Measured: baseline (month 0), post-intervention (month 3)
Change in body composition from baseline to post-intervention.
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Measured: baseline (month 0), post-intervention (month 3)
Change in waist circumference from baseline to post-intervention.
Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation.
Measured: baseline (month 0), post-intervention (month 3)
Change in sagittal abdominal diameter from baseline to post-intervention.
Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation.
Measured: baseline (month 0), post-intervention (month 3)
Change in physical activity from baseline to post-intervention.
Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ).
Measured: baseline (month 0), post-intervention (month 3)
Change in health-related quality of life from baseline to post-intervention.
Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23).
Measured: baseline (month 0), post-intervention (month 3)
Change in self-efficacy from baseline to post-intervention.
Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire.
Measured: baseline (month 0), post-intervention (month 3)
Use of weight management strategies
The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).
Measured: post-intervention (month 3)
Height
Height will be assessed in order to determine BMI.
Measured: baseline (month 0)
Change in blood pressure from baseline to post-intervention.
Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes.
Measured: post-intervention (month 3), follow-up (month 9)
Change in LDL cholesterol at from baseline to post-intervention.
Measured: baseline (month 0), post-intervention (month 3)
Change in total cholesterol from baseline to post-intervention.
Measured: baseline (month 0), post-intervention (month 3)
Change in triglycerides from baseline to post-intervention.
Measured: baseline (month 0), post-intervention (month 3)
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.
Measured: post-intervention (month 3), follow-up (month 9)
Change in HDL Cholesterol from post-intervention to follow-up.
Measured: post-intervention (month 3), follow-up (month 9)
Change in blood glucose control from post-intervention to follow-up.
Measured: post-intervention (month 3), follow-up (month 9)
Change in caloric intake from post-intervention to follow-up.
National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake.
Measured: post-intervention (month 3), follow-up (month 9)
Change in body composition from post-intervention to follow-up.
Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).
Measured: post-intervention (month 3), follow-up (month 9)
Change in waist circumference from post-intervention to follow-up.
Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation.
Measured: post-intervention (month 3), follow-up (month 9)
Change in sagittal abdominal diameter from post-intervention to follow-up.
Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation.
Measured: post-intervention (month 3), follow-up (month 9)
Change in physical activity from post-intervention to follow-up.
Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ).
Measured: post-intervention (month 3), follow-up (month 9)
Change in health-related quality of life from post-intervention to follow-up.
Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23).
Measured: post-intervention (month 3), follow-up (month 9)
Change in self-efficacy from post-intervention to follow-up.
Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire.
Measured: post-intervention (month 3), follow-up (month 9)
Use of weight management strategies at follow-up.
The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).
Measured: follow-up (month 9)
Change in blood pressure from post-intervention to follow-up.
Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes.
Measured: post-intervention (month 3), follow-up (month 9)
Change in LDL cholesterol at from post-intervention follow-up
Measured: post-intervention (month 3), follow-up (month 9)
Change in total cholesterol from post-intervention to follow-up.
Measured: post-intervention (month 3), follow-up (month 9)
Change in triglycerides from post-intervention to follow-up.
Measured: post-intervention (month 3), follow-up (month 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Mathews, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630499
- Sponsor's protocol ID
- MyLIFE2012
- Other IDs
- 427-2012
- Acronym
- MyLIFE
- Status last verified
- Sep 2016
- First submitted
- 22 Jun 2012
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pharoah PD, Day NE, Duffy S, Easton DF, Ponder BA. Family history and the risk of breast cancer: a systematic review and meta-analysis. Int J Cancer. 1997 May 29;71(5):800-9. doi: 10.1002/(sici)1097-0215(19970529)71:53.0.co;2-b.
PubMed 9180149McTiernan A. Behavioral risk factors in breast cancer: can risk be modified? Oncologist. 2003;8(4):326-34. doi: 10.1634/theoncologist.8-4-326.
PubMed 12897329King MC, Marks JH, Mandell JB; New York Breast Cancer Study Group. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003 Oct 24;302(5645):643-6. doi: 10.1126/science.1088759.
PubMed 14576434Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
PubMed 12711737Berclaz G, Li S, Price KN, Coates AS, Castiglione-Gertsch M, Rudenstam CM, Holmberg SB, Lindtner J, Erien D, Collins J, Snyder R, Thurlimann B, Fey MF, Mendiola C, Werner ID, Simoncini E, Crivellari D, Gelber RD, Goldhirsch A; International Breast Cancer Study Group. Body mass index as a prognostic feature in operable breast cancer: the International Breast Cancer Study Group experience. Ann Oncol. 2004 Jun;15(6):875-84. doi: 10.1093/annonc/mdh222.
PubMed 15151943Nichols HB, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Holmes MD, Bersch AJ, Holick CN, Hampton JM, Stampfer MJ, Willett WC, Newcomb PA. Body mass index before and after breast cancer diagnosis: associations with all-cause, breast cancer, and cardiovascular disease mortality. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1403-9. doi: 10.1158/1055-9965.EPI-08-1094. Epub 2009 Apr 14.
PubMed 19366908Gallicchio L, Kalesan B, Hoffman SC, Helzlsouer KJ. Non-cancer adverse health conditions and perceived health and function among cancer survivors participating in a community-based cohort study in Washington County, Maryland. J Cancer Surviv. 2008 Mar;2(1):12-9. doi: 10.1007/s11764-008-0046-1. Epub 2008 Feb 12.
PubMed 18648983Fossa SD, Vassilopoulou-Sellin R, Dahl AA. Long term physical sequelae after adult-onset cancer. J Cancer Surviv. 2008 Mar;2(1):3-11. doi: 10.1007/s11764-007-0039-5. Epub 2007 Dec 4.
PubMed 18648982Chen Z, Maricic M, Bassford TL, Pettinger M, Ritenbaugh C, Lopez AM, Barad DH, Gass M, Leboff MS. Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):552-8. doi: 10.1001/archinte.165.5.552.
PubMed 15767532Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.
PubMed 15850868Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343.
PubMed 16314649Robien K, Demark-Wahnefried W, Rock CL. Evidence-based nutrition guidelines for cancer survivors: current guidelines, knowledge gaps, and future research directions. J Am Diet Assoc. 2011 Mar;111(3):368-75. doi: 10.1016/j.jada.2010.11.014. No abstract available.
PubMed 21338735Coussens LM, Werb Z. Inflammation and cancer. Nature. 2002 Dec 19-26;420(6917):860-7. doi: 10.1038/nature01322.
PubMed 12490959Shacter E, Weitzman SA. Chronic inflammation and cancer. Oncology (Williston Park). 2002 Feb;16(2):217-26, 229; discussion 230-2.
PubMed 11866137Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
PubMed 20071471
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.
- ClinicalTrials.gov ID
- NCT01630499
- Acronym / sponsor ID
- MyLIFE / MyLIFE2012
- Conditions
- Breast Cancer
- Keywords
- Cancer, Breast cancer, Breast cancer prevention, Breast cancer recurrence, Weight loss, Weight management, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Lifestyle Intervention (TLI) | Experimental | Behavioral: Tailored Lifestyle Intervention (TLI)Participants randomized to the TLI condition will receive a 3-month weight management program tailored to the specific needs of women in remission from breast cancer. |
| Commercial Weight Loss Program (CLWP) | Active comparator | Behavioral: Commercial Weight Loss Program (CWLP)Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age 21 to 65
- History of stage 1, 2, or 3 breast cancer
- Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent
- Be willing/able to attend groups and assessments in Gainesville or Jacksonville
Key exclusion criteria (27 listed)
- History of bariatric surgery
- Pregnant, lactating, or planning on becoming pregnant in next 12 months.
- Irritable bowel syndrome
- Serious infectious disease
- Chronic malabsorption syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Lifestyle Intervention (TLI)The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors. | Behavioural | Tailored Lifestyle Intervention (TLI) |
| Commercial Weight Loss Program (CWLP)This intervention is a generic, widely-available weight management program. | Behavioural | Commercial Weight Loss Program (CLWP) |
Primary outcome
Change in body weight from baseline to post-intervention
Time frame: baseline (month 0), post-intervention (month 3)
Change in body weight from post-intervention to follow-up
Time frame: post-intervention (month 3), follow-up (month 9)
31 secondary outcomes
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention
Time frame: baseline (month 0), post-intervention (month 3)
Change in HDL Cholesterol from baseline to post-intervention
Time frame: baseline (month 0), post-intervention (month 3)
Change in blood glucose control from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in caloric intake from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in body composition from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in waist circumference from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in sagittal abdominal diameter from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in physical activity from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in health-related quality of life from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in self-efficacy from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Use of weight management strategies
Time frame: post-intervention (month 3)
Height
Time frame: baseline (month 0)
Change in blood pressure from baseline to post-intervention.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in LDL cholesterol at from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in total cholesterol from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in triglycerides from baseline to post-intervention.
Time frame: baseline (month 0), post-intervention (month 3)
Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in HDL Cholesterol from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in blood glucose control from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in caloric intake from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in body composition from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in waist circumference from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in sagittal abdominal diameter from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in physical activity from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in health-related quality of life from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in self-efficacy from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Use of weight management strategies at follow-up.
Time frame: follow-up (month 9)
Change in blood pressure from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in LDL cholesterol at from post-intervention follow-up
Time frame: post-intervention (month 3), follow-up (month 9)
Change in total cholesterol from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Change in triglycerides from post-intervention to follow-up.
Time frame: post-intervention (month 3), follow-up (month 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Background: PubMed 9180149Pharoah PD, Day NE, Duffy S, Easton DF, Ponder BA. Family history and the risk of breast cancer: a systematic review and meta-analysis. Int J Cancer. 1997 May 29;71(5):800-9. doi: 10.1002/(sici)1097-0215(19970529)71:53.0.co;2-b.
- Background: PubMed 12897329McTiernan A. Behavioral risk factors in breast cancer: can risk be modified? Oncologist. 2003;8(4):326-34. doi: 10.1634/theoncologist.8-4-326.
- Background: PubMed 14576434King MC, Marks JH, Mandell JB; New York Breast Cancer Study Group. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003 Oct 24;302(5645):643-6. doi: 10.1126/science.1088759.
- Background: PubMed 12711737Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
- Background: PubMed 15151943Berclaz G, Li S, Price KN, Coates AS, Castiglione-Gertsch M, Rudenstam CM, Holmberg SB, Lindtner J, Erien D, Collins J, Snyder R, Thurlimann B, Fey MF, Mendiola C, Werner ID, Simoncini E, Crivellari D, Gelber RD, Goldhirsch A; International Breast Cancer Study Group. Body mass index as a prognostic feature in operable breast cancer: the International Breast Cancer Study Group experience. Ann Oncol. 2004 Jun;15(6):875-84. doi: 10.1093/annonc/mdh222.
- Background: PubMed 19366908Nichols HB, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Holmes MD, Bersch AJ, Holick CN, Hampton JM, Stampfer MJ, Willett WC, Newcomb PA. Body mass index before and after breast cancer diagnosis: associations with all-cause, breast cancer, and cardiovascular disease mortality. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1403-9. doi: 10.1158/1055-9965.EPI-08-1094. Epub 2009 Apr 14.
- Background: PubMed 18648983Gallicchio L, Kalesan B, Hoffman SC, Helzlsouer KJ. Non-cancer adverse health conditions and perceived health and function among cancer survivors participating in a community-based cohort study in Washington County, Maryland. J Cancer Surviv. 2008 Mar;2(1):12-9. doi: 10.1007/s11764-008-0046-1. Epub 2008 Feb 12.
- Background: PubMed 18648982Fossa SD, Vassilopoulou-Sellin R, Dahl AA. Long term physical sequelae after adult-onset cancer. J Cancer Surviv. 2008 Mar;2(1):3-11. doi: 10.1007/s11764-007-0039-5. Epub 2007 Dec 4.
- Background: PubMed 15767532Chen Z, Maricic M, Bassford TL, Pettinger M, Ritenbaugh C, Lopez AM, Barad DH, Gass M, Leboff MS. Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):552-8. doi: 10.1001/archinte.165.5.552.
- Background: PubMed 15850868Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.
- Background: PubMed 16314649Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343.
- Background: PubMed 21338735Robien K, Demark-Wahnefried W, Rock CL. Evidence-based nutrition guidelines for cancer survivors: current guidelines, knowledge gaps, and future research directions. J Am Diet Assoc. 2011 Mar;111(3):368-75. doi: 10.1016/j.jada.2010.11.014. No abstract available.
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Mathews, PhD, RD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Lifestyle Intervention (TLI) and Commercial Weight Loss Program (CWLP) in people with Breast Cancer, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline to post-intervention (time frame: baseline (month 0), post-intervention (month 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630499, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.