Clinical trial · Interventional
TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors
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)
NCT02466061CI-TRIAL-00022450completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care Group (Arm C) | Behavioral | — | UNRESOLVED |
| Telemedicine Weight Management plus Wi-Fi Scale (Arm A) | Behavioral | — | UNRESOLVED |
| Text for Diet (Text4Diet) Group (Arm B) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Telemedicine 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.
- interventionNames
- Behavioral: Telemedicine Weight Management plus Wi-Fi Scale (Arm A)
- type
- EXPERIMENTAL
- label
- Arm B: Text for Diet (Text4Diet) 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHaggerty 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. PMID 29086522