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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 6
- 主要终点
- Change in Weight (kilograms)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Change in Weight (kilograms)
时间窗: Change from Baseline Weight at 6 months
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.
Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL
时间窗: Change from Baseline IGFBP-1 at 6 months
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.
Serum biomarker: Change in levels of Adiponectin, in ug/mL
时间窗: Change from Baseline Adiponectin at 6 months
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.
Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL
时间窗: Change from Baseline VEGF at 6 months
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.
Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL
时间窗: Change from Baseline IL1-beta at 6 months
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.
Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL
时间窗: Change from Baseline IL2 at 6 months
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.
Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL
时间窗: Change from Baseline IL6 at 6 months
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.
Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL
时间窗: Change from Baseline IL7 at 6 months
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.
Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL
时间窗: Change from Baseline IL8 at 6 months
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.
Serum biomarker: Change in C reactive protein (CRP), in mg/L
时间窗: Change from Baseline CRP at 6 months
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.
次要结局
- 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)
- Psychosocial measure: Change in Physical Activity(Change from Baseline Physical Activity at 6 months)