Clinical trial NCT02466061: TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: BMI >= 30 kg/m2
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Pennsylvania
name: Washington University School of Medicine
name: Dana-Farber Cancer Institute
First posted: 2015-06-09
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

Aim 2

1. Women 18 years of age or older and with biopsy-proven endometrial cancer,
2. Body Mass Index (BMI) greater than or equal to 30 kg/m2 (based on most recent routine clinical measurement recorded in patient's medical record),
3. Must be able to read and speak English fluently, and
4. All patients must be informed of the investigational nature of the Aim 2 survey study and must give written informed consent for Aim 2 study activities in accordance with institutional and federal guidelines. (Aim 2 consent is obtained and documented as described on page 1 of the Endometrial Cancer Questionnaire).

Aim 1

1. Woman who was recruited to and completed Aim 2 of the study,
2. Has completed prior surgical or other medical management and adjuvant endometrial cancer treatment, prior to starting Aim 1,
3. Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of randomization AND, after randomization, it is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention,
4. No evidence of active endometrial cancer disease as determined by physician evaluation prior to randomization,
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Life expectancy of at least one year,
7. Must have access to either wireless Internet, or a smart phone such as an Android or Apple iPhone, and
8. All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.

Exclusion Criteria:

Aim 2

1. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 2 protocol compliance or a participant's ability to give informed consent.

   4.3.2.2 Aim 1
2. Must not be participating in another weight loss program or taking weight loss medications,
3. No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a Patient Health Questionnaire (PHQ-9) score \>19, or a score of ≥1 on the suicidal ideation item (#9 on the PHQ-9)
4. No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 5 years. Carcinosarcoma is not excluded as the investigators are including women with Type I and II endometrial cancer. For the purposes of the trial, carcinosarcoma falls into the Type II category.
5. No diagnoses of autoimmune disorders (including lupus, rheumatoid arthritis, Siogren's syndrome, Crohn's disease and ulcerative colitis), immune-compromised disorders (i.e., HIV/AIDS),
6. Not receiving at time of randomization, and not expected to receive at any time during the Aim 1 intervention, any medications that may affect the inflammatory markers of interest (i.e., steroids, immunosuppressants or transplant medications), and
7. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 1 protocol compliance or a participant's ability to give informed consent.
8. Must not be pregnant.

Primary outcomes:
measure: Change in Weight (kilograms)
timeFrame: Change from Baseline Weight at 6 months
measure: Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL
timeFrame: Change from Baseline IGFBP-1 at 6 months
measure: Serum biomarker: Change in levels of Adiponectin, in ug/mL
timeFrame: Change from Baseline Adiponectin at 6 months
measure: Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL
timeFrame: Change from Baseline VEGF at 6 months
measure: Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL
timeFrame: Change from Baseline IL1-beta at 6 months
measure: Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL
timeFrame: Change from Baseline IL2 at 6 months
measure: Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL
timeFrame: Change from Baseline IL6 at 6 months
measure: Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL
timeFrame: Change from Baseline IL7 at 6 months
measure: Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL
timeFrame: Change from Baseline IL8 at 6 months
measure: Serum biomarker: Change in C reactive protein (CRP), in mg/L
timeFrame: Change from Baseline CRP at 6 months
Secondary outcomes:
measure: Knowledge of the association between obesity and endometrial cancer risk
timeFrame: Baseline
measure: Psychosocial measure: Change in Body Image
timeFrame: Change from Baseline Body Image at 6 months
measure: Psychosocial measure: Change in Quality of Life
timeFrame: Change from Baseline in Quality of Life at 6 months
measure: Psychosocial measure: Change in Mood
timeFrame: Change from Baseline in Mood at 6 months
measure: Psychosocial measure: Change in Sexual Functioning
timeFrame: Change from Baseline in Sexual Functioning at 6 months
measure: Psychosocial measure: Change in Physical Activity
timeFrame: Change from Baseline Physical Activity at 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University in St Louis (Siteman Cancer Center)
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kelly Allison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haggerty AF, Hagemann A, Barnett M, Thornquist M, Neuhouser ML, Horowitz N, Colditz GA, Sarwer DB, Ko EM, Allison KC. A Randomized, Controlled, Multicenter Study of Technology-Based Weight Loss Interventions among Endometrial Cancer Survivors. Obesity (Silver Spring). 2017 Nov;25 Suppl 2(Suppl 2):S102-S108. doi: 10.1002/oby.22021.