NCT02466061

TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Interventions

Type	Name	Description
BEHAVIORAL	Telemedicine Weight Management plus Wi-Fi Scale (Arm A)	Telephonic weight loss counseling by trained interventionists, with guided digital scale measurements of weight, lean mass, and fat mass. Counseling sessions and digital weight recording occur at regularly scheduled intervals over a six-month intervention period.
BEHAVIORAL	Text for Diet (Text4Diet) Group (Arm B)	Short Message Service (SMS) text messaging in which participants receive 3-5 text messages each day during a six-month intervention period. The text messages provide tips and reminders to encourage healthy eating and weight loss. Participants on this arm also receive a digital scale to track and report weight as prompted once per week through the text program.
BEHAVIORAL	Enhanced Usual Care Group (Arm C)	Participants are provided with handouts based on American Cancer Society guidelines for healthy eating and exercise.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-06-09
• Last updated: 2016-06-02

Locations

3 sites across 1 country: United States