Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-29 @ 12:15 PM
Study NCT ID:
NCT02466061
Status:
COMPLETED
Last Update Posted:
2016-06-02
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official 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)
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01CA116850 | NIH | None | https://reporter.nih.gov/quic… | View |
| U54CA155850 | NIH | None | https://reporter.nih.gov/quic… | View |
| U54CA155496 | NIH | None | https://reporter.nih.gov/quic… | View |
| U54CA155626 | NIH | None | https://reporter.nih.gov/quic… | View |