TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Endometrial Cancer

Treatments: Behavioral: Text for Diet (Text4Diet) Group (Arm B); Behavioral: Enhanced Usual Care Group (Arm C); Behavioral: Telemedicine Weight Management plus Wi-Fi Scale (Arm A)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02466061

U54CA155496 (U.S. NIH Grant/Contract)

TREC 1190

U01CA116850 (U.S. NIH Grant/Contract)

U54CA155850

U54CA155626 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

207 participants in 3 patient groups

Arm A: Telemedicine Group

Experimental group

Description:

Telemedicine Weight Management plus Wi-Fi Scale (Arm A) Participants in the Telemedicine Group will receive a Wi-Fi Scale that measures weight, lean mass, and fat mass. Participants will receive 15-20 minute telephone counseling sessions by phone. Sessions will occur at routine intervals during the six month intervention period. All Aim 1 participants, including those randomized to Arm A, will complete a packet of psychosocial measures at baseline and 6 months (final assessment). Month 12 followup weight data also will be collected through medical record abstraction.

Treatment:

Behavioral: Telemedicine Weight Management plus Wi-Fi Scale (Arm A)

Arm B: Text for Diet (Text4Diet) Group

Experimental group

Description:

Text for Diet (Text4Diet) Group (Arm B) The intervention in this Arm involves delivery of Short Message Service (SMS) text messages to participants each day over the course of a 6 month intervention period. Participants will also receive a digital scale to track weight on a weekly basis. SMS text messages will be sent 2-3 times per day and will provide feedback, support, prompting, and strategies to adhere to behaviors associated with long-term weight management. All Aim 1 participants, including those randomized to Arm B, will complete a packet of psychosocial measures at baseline and 6 months (final assessment). Month 12 follow up weight data also will be collected through medical record abstraction.

Treatment:

Behavioral: Text for Diet (Text4Diet) Group (Arm B)

Arm C: Enhanced Usual Care Group

Active Comparator group

Description:

Enhanced Usual Care Group (Arm C) Participants will be provided with handouts based on American Cancer Society guidelines on healthy eating and exercise. All Aim 1 participants, including those randomized to Arm C, will complete a packet of psychosocial measures at baseline and 6 months (final assessment). Month 12 follow up weight data also will be collected through medical record abstraction.

Treatment:

Behavioral: Enhanced Usual Care Group (Arm C)