TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors

NCT02466061 | Completed

• 5 other identifiers: TREC 1190U01CA116850U54CA155850U54CA155496U54CA155626
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometrial Cancer

Keywords

BMI >= 30 kg/m2

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

• Knowledge of the association between obesity and endometrial cancer risk

  Baseline

• Psychosocial measure: Change in Body Image

  Change from Baseline Body Image at 6 months

• Psychosocial measure: Change in Quality of Life

  Change from Baseline in Quality of Life at 6 months

• Psychosocial measure: Change in Mood

  Change from Baseline in Mood at 6 months

• Psychosocial measure: Change in Sexual Functioning

  Change from Baseline in Sexual Functioning at 6 months

Study Arms (3)

Arm A: Telemedicine Group

EXPERIMENTAL

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.

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

Arm B: Text for Diet (Text4Diet) Group

EXPERIMENTAL

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.

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

Arm C: Enhanced Usual Care Group

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care Group (Arm C)

Interventions

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

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.

Also known as: Telemedicine Group

Arm A: Telemedicine Group

Text for Diet (Text4Diet) Group (Arm B) BEHAVIORAL

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.

Also known as: Text4Diet Group

Arm B: Text for Diet (Text4Diet) Group

Enhanced Usual Care Group (Arm C) BEHAVIORAL

Participants are provided with handouts based on American Cancer Society guidelines for healthy eating and exercise.

Also known as: Enhanced Usual Care Group

Arm C: Enhanced Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Pennsylvania: collaborator
• Washington University School of Medicine: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University in St Louis (Siteman Cancer Center)

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 29086522 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Diet; Population Groups

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Demography; Population Characteristics

Study Officials

• Kelly Allison, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-06

Locations

US (3)