TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

Endometrial Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466061
• Other study ID #: TREC 1190
• Secondary ID: U01CA116850U54CA
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: June 1, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• 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.
• Enhanced Usual Care Group (Arm C)
Participants are provided with handouts based on American Cancer Society guidelines for healthy eating and exercise.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University in St Louis (Siteman Cancer Center)	St. Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Dana-Farber Cancer Institute, National Cancer Institute (NCI), University of Pennsylvania, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Weight at 6 months	No
Primary	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.	Change from Baseline IGFBP-1 at 6 months	Yes
Primary	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.	Change from Baseline Adiponectin at 6 months	Yes
Primary	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.	Change from Baseline VEGF at 6 months	Yes
Primary	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.	Change from Baseline IL1-beta at 6 months	Yes
Primary	Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL	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.	Change from Baseline IL2 at 6 months	Yes
Primary	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.	Change from Baseline IL6 at 6 months	Yes
Primary	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.	Change from Baseline IL7 at 6 months	Yes
Primary	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.	Change from Baseline IL8 at 6 months	Yes
Primary	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.	Change from Baseline CRP at 6 months	Yes
Secondary	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.	Baseline	No
Secondary	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).	Change from Baseline Body Image at 6 months	No
Secondary	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).	Change from Baseline in Quality of Life at 6 months	No
Secondary	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).	Change from Baseline in Mood at 6 months	No
Secondary	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).	Change from Baseline in Sexual Functioning at 6 months	No
Secondary	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).	Change from Baseline Physical Activity at 6 months	No

External Links

•   Public page for the Transdisciplinary Research on Energetics and Cancer NCI Initiative