Healthy Living After Cancer: Weight Management Pilot Study
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|ClinicalTrials.gov Identifier: NCT01978899|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : June 3, 2016
Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors.
This study is designed to look at the ability of a 15-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Program After Cancer Diagnosis||Behavioral: Immediate Weight Loss Program Group Behavioral: Delayed Weight Loss Program Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Healthy Living After Cancer: Weight Management Pilot Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
Active Comparator: Immediate Weight Loss Program Group
Immediate Weight Loss Program Group
Behavioral: Immediate Weight Loss Program Group
Participation in 15-week Healthy Living Program.
Active Comparator: Delayed Weight Loss Program Group
The Delayed Weight Loss Program Group will take part in the weight loss intervention after the 16-week control period. Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks
Behavioral: Delayed Weight Loss Program Group
Participation in 15-week Healthy Living Program following 15-week wait period.
- To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors. [ Time Frame: 2 Years ]Change in weight (post-pre)weight loss intervention
- To evaluate the impact of a 15-week weight loss intervention upon the following in a group of cancer survivors. [ Time Frame: 2 Years ]Correlate the effect of the intervention with anthropometric outcomes of percentage change or differences, changes in QOL, physical activity, or body image relative to baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978899
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer Ligibel, MD||Dana-Farber Cancer Institute|