NCT01978899|CompletedDMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 8, 2013
Actual (reported)December 2015
Actual (reported)February 2016
Actual (reported)To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors.
Change in weight (post-pre)weight loss intervention
2 Years
To evaluate the impact of a 15-week weight loss intervention upon the following in a group of cancer survivors.
2 Years
Immediate Weight Loss Program Group * The weight loss Program Group will include weekly in-person sessions comprised of dietary counseling and increased physical activity. Patients will also be provided with exercise and dietary goals each week to implement at home. * Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks.
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
Participation in 15-week Healthy Living Program.
Participation in 15-week Healthy Living Program following 15-week wait period.
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Brown JC, Giobbie-Hurder A, Yung RL, Mayer EL, Tolaney SM, Partridge AH, Ligibel JA. The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. Psychooncology. 2022 Feb;31(2):326-333. doi: 10.1002/pon.5817. Epub 2021 Sep 12.
Jennifer Ligibel, MD
Dana-Farber Cancer Institute
60 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2013
First Posted
November 8, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
June 3, 2016
Record last verified: 2016-06
There are no plans to release individual participant data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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