Behavioral Weight Loss and Exercise After Treatment (BEAT) (BEAT)
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|ClinicalTrials.gov Identifier: NCT02052115|
Recruitment Status : Unknown
Verified December 2014 by Kim Dittus, University of Vermont.
Recruitment status was: Recruiting
First Posted : January 31, 2014
Last Update Posted : December 3, 2014
Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.
This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: 12 month exercise and weight loss intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Exercise and weight loss
12 month exercise and weight loss intervention
|Behavioral: 12 month exercise and weight loss intervention|
- Correlation of executive function and weight loss success [ Time Frame: 12 months ]Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.
- Correlation of cancer related symptoms and weight loss [ Time Frame: 12 months ]Determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months
- Efficacy of a weight loss intervention [ Time Frame: 12 months ]Determine the effectiveness of a behavioral weight loss and exercise intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052115
|Contact: Kim Dittus, MD, PhDemail@example.com|
|Contact: Karen Wilson, CCRPfirstname.lastname@example.org|
|United States, Vermont|
|Vermont Cancer Center||Recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: Kim Dittus, MD, PhD 802-656-5470 email@example.com|
|Contact: Karen Wilson, MEd, CCRP 802-656-4101 firstname.lastname@example.org|
|Principal Investigator: Kim Dittus, MD, PhD|
|Principal Investigator:||Kim Dittus, MD, PhD||University of Vermont|