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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
207
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.
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.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University in St Louis (Siteman Cancer Center)
St Louis, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Change in Weight (kilograms)
Change in weight (in kilograms) of study participants randomized to one of three weight loss intervention programs will be assessed. Measurement of this change will be evaluated from weights taken at baseline (randomization) and six months, the conclusion of the intervention program.
Time frame: Change from Baseline Weight at 6 months
Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL
Change in IGFBP-1 (in ng/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IGFBP-1 at 6 months
Serum biomarker: Change in levels of Adiponectin, in ug/mL
Change in Adiponectin (in ug/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline Adiponectin at 6 months
Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL
Change in VEGF (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline VEGF at 6 months
Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL
Change in IL1-beta (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IL1-beta at 6 months
Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL
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Participants are provided with handouts based on American Cancer Society guidelines for healthy eating and exercise.
Change in IL2 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IL2 at 6 months
Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL
Change in IL6 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IL6 at 6 months
Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL
Change in IL7 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IL7 at 6 months
Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL
Change in IL8 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline IL8 at 6 months
Serum biomarker: Change in C reactive protein (CRP), in mg/L
Change in CRP (in mg/L) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program.
Time frame: Change from Baseline CRP at 6 months
Knowledge of the association between obesity and endometrial cancer risk
Participants' level of knowledge of the association between obesity and the risk of endometrial cancer will be assessed at baseline. Frequencies of categorical responses will be reported. The instrument used to collect this data is a participant completed Endometrial Cancer Questionnaire and was developed by the study investigators.
Time frame: Baseline
Psychosocial measure: Change in Body Image
Change in participants' self-reported body image will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Two validated, participant-completed instruments will be utilized to assess this outcome: the Multidimensional Body Self Relations Questionnaire-Appearance Subscales (MBSRQ-AS) and the Cancer-Related Body Image Scale (CRBI).
Time frame: Change from Baseline Body Image at 6 months
Psychosocial measure: Change in Quality of Life
Change in participants' self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the 12-Item Short Form Health Survey (SF-12).
Time frame: Change from Baseline in Quality of Life at 6 months
Psychosocial measure: Change in Mood
Change in participants' self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the Patient Health Questionnaire 9-Item Version (PHQ-9).
Time frame: Change from Baseline in Mood at 6 months
Psychosocial measure: Change in Sexual Functioning
Change in participants' self-reported sexual functioning will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Three validated, participant-completed instruments will be utilized to assess this outcome: the Female Sexual Function Index (FSFI), the Dyadic Adjustment Scale (DAS), and the Female Sexual Distress Scale-Revised (FSDS-R).
Time frame: Change from Baseline in Sexual Functioning at 6 months
Psychosocial measure: Change in Physical Activity
Change in participants' self-reported physical activity will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the International Physical Activity Questionnaire Short Form (IPAQ).
Time frame: Change from Baseline Physical Activity at 6 months