Metadata record for the article: Randomized Trial of Weight Loss on Circulating Ghrelin Levels Among Breast Cancer Survivors
Creators: name: Puklin, Leah
name: Cartmel, Brenda
name: Harrigan, Maura
name: Lingeng Lu
name: Fang-Yong Li
name: Sanft, Tara
name: Irwin, Melinda L.
Publisher: name: figshare
Year: 2021
Subjects: subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: 119999 Medical and Health Sciences not elsewhere classified
subject: FOS: Other medical sciences
subject: FOS: Other medical sciences
subject: Cancer
subject: 111299 Oncology and Carcinogenesis not elsewhere classified
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: Diseases

description: <b>Summary</b><br> This metadata record provides details of the data supporting the claims of the related article: “Randomized Trial of Weight Loss on Circulating Ghrelin Levels Among Breast Cancer Survivors”. The related study aimed to determine the effect of a lifestyle intervention on ghrelin levels in breast cancer survivors with a body mass index (BMI) &gt;25 kg/m2, as obesity among breast cancer survivors is associated with increased risk for recurrence and mortality. Type of data: baseline associations between ghrelin, body composition, and blood biomarkers; clinical data Subject of data: <i>Homo sapiens</i> Sample size: 151 Population characteristics: Eligible participants were breast cancer survivors with a BMI ≥ 25.0 kg/m2, diagnosed in the 5 years before enrollment with stage 0 to 3 breast cancer, who had completed chemotherapy and/or radiation therapy at least 3 months before enrollment. Women had to be physically able to walk, agree to be randomly assigned, and give informed consent to participate in all study activities. They had to be accessible by telephone and English literate. Women were ineligible if they were pregnant or intending to become pregnant in the next year, had experienced a recent (past 6 months) stroke or myocardial infarction, or had severe uncontrolled mental illness. Recruitment: Participants were identified through medical oncology clinics or self-referred via study brochures in the Breast Center at Smilow Cancer Hospital at Yale-New Haven Hospital and the Yale Cancer Center Survivorship Clinic. Date of data collection: June 1 2011 - February 1 2016 Trial registration number: NCT02109068 and NCT02110641 <b>Data access</b> The data supporting the findings of the related study are contained in the following files: ‘Consort_Diagram.xlsx’, ‘FinalCode_Table1_2_Ghrelin.sas7bdat’ and ‘FinalCode_Table3_Ghrelin.sas7bdat’. However, these data are not publicly available in order to protect patient privacy. A complete de-identified patient-level dataset, study protocol and statistical analysis plan will be made available to researchers upon request until December 2025 by contacting the corresponding author. <b>Corresponding author(s) for this study</b> Leah Puklin, MPH. Yale University School of Public Health, 60 College St., New Haven, CT, 06510 USA. Email: leah.puklin@yale.edu <br> <b>Study approval </b> The Yale School of Medicine Human Investigation Committee approved all procedures, including written informed consent.