TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

NCT ID: NCT02466061


Title
Transdisciplinary Research on Energetics (TREC) and Cancer Cross Center Study / Obesity and Weight Loss in Endometrial Cancer Survivors: A Randomized, Multi-site Trial (Lifestyle Beyond Cancer Study)
Purpose
This randomized, controlled study evaluates the efficacy of weigh loss interventions in endometrial cancer survivors, using novel technology-based weight loss platforms. This is a multi-site, pilot feasibility study which will provide preliminary data to support a larger NIH funded, mult-center trial.
Details
Study Aims The relationship between endometrial cancer (EC) and obesity is well established. However, few studies have examined the acceptability and potential efficacy of an intervention to promote weight reduction and alter cancer-associated biomarkers in endometrial cancer survivors. This investigation has two specific aims. Aim 1: To compare the efficacy of novel technology-based weight loss interventions: a) telephone encounters and wireless scales, or b) smart phone personalized text messaging as compared to c) an enhanced usual care group for women with obesity and a history of endometrial cancer. Hypothesis: Women in both the telemedicine and text intervention arms will lose significantly more weight than women in the enhanced usual care arm. Aim 2: 1a) To explore patients' understanding of the relationship between obesity and endometrial cancer and, 1b) to survey the acceptability of novel and different approaches to weight loss. Hypothesis: The investigators anticipate that this study will validate pilot data from a predecessor single-institution study demonstrating that >25% of patients will not be aware of the association between excess body weight and endometrial cancer. Investigators also will assess the acceptability of various interventions designed to promote weight loss (i.e. in person counseling, phone-based, text messaging) and predict a greater interest in interventions that require fewer in-person visits to the clinic. Study Design Aim 1: - 3 arm randomized controlled trial, weight loss intervention - Pre and post intervention patient reported psychosocial measures - Pre and post intervention Dual-energy X-ray absorptiometry (DEXA) to explore impact of weight loss on body fat distribution - Pre and post intervention analyses of the following biomarkers: insulin-like growth factor-binding protein 1 (IGFBP-1); adiponectin, vascular endothelial growth factor (VEGF), C reactive protein (CRP), interleukin 1-beta (IL1-beta), interleukin 2 (IL2), interleukin 6 (IL6), interleukin 7 (IL7), and interleukin 8 (IL8) Aim 2: Patient-reported survey to assess knowledge of correlation of Body Mass Index (BMI) with endometrial cancer incidence Study Population Aim 2: Adult women with biopsy-proven endometrial cancer (Types I and II), BMI ≥ 30 kg/m2. Aim 1: Aim 2 population plus Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1, no concurrent chemo or radiation therapy, and access to wireless internet and/or smart phone device.
Conditions
Endometrial Cancer
Keywords
BMI >= 30 kg/m2
Source
Fred Hutchinson Cancer Research Center
Sponsors
Fred Hutchinson Cancer Research Center, National Cancer Institute (NCI), University of Pennsylvania, Washington University School of Medicine, Dana-Farber Cancer Institute
Status
Completed
Acronym
Last Updated
31 May 2016
URL
Official Link
Locations
United States