TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

Completed · Not applicable

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT02466061

Run by

Fred Hutchinson Cancer Center

People needed

207

Starts

2014-07-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Aim 2
• Women 18 years of age or older and with biopsy-proven endometrial cancer,
• 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),
• Must be able to read and speak English fluently, and
• 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
• Woman who was recruited to and completed Aim 2 of the study,
• Has completed prior surgical or other medical management and adjuvant endometrial cancer treatment, prior to starting Aim 1,
• 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,
• No evidence of active endometrial cancer disease as determined by physician evaluation prior to randomization,
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of at least one year,
• Must have access to either wireless Internet, or a smart phone such as an Android or Apple iPhone, and
• 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.

You may not qualify if…

• Aim 2
• 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.
• 3.2.2 Aim 1
• Must not be participating in another weight loss program or taking weight loss medications,
• 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)
• 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.
• 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),
• 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
• 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.
• Must not be pregnant.

Where it is running

• 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

Full record on ClinicalTrials.gov

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