临床试验/NCT05930483

NCT05930483招募中不适用

Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study

Fred Hutchinson Cancer Center2 个研究点分布在 1 个国家目标入组 640 人开始时间: 2025年4月8日最近更新: 2026年6月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Fred Hutchinson Cancer Center
入组人数: 640
试验地点: 2
主要终点: Body weight (kg) percent change

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.

详细描述

OUTLINE: This sequential multiple assignment randomized trial (SMART) will test four different community-aligned 12-month adaptive weight loss interventions.

BASELINE: Participants receive written instructions and website link to complete surveys along with supportive materials including a measuring tape, Bluetooth-enabled scale, and may receive an Actigraph accelerometer to be worn for 7 days at baseline. Participants also undergo blood sample collection at baseline.

STAGE ONE: Eligible participants from the baseline run-in are randomized to participate in Stage One. In Stage One, participants are randomized to one of two groups: ¡Vida! or ¡Vida! Plus.

STAGE TWO: Percent weight loss is measured at week 8. Women who lose ≥2% of their body weight at week 8 will be considered "Responders" and will continue with their original randomization assignment in Stage Two.

Women in the Stage One ¡Vida! group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus or ¡Vida! Plus + health coaching (HC). Women in the Stage One ¡Vida! Plus group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus + HC or ¡Vida! Plus + HC + mailed toolkits (MT).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Prevention
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

•Biologically female
•Age >= 18 years
•Self-identifies Hispanic/Latina
•Able to read and write in Spanish and/or English
•Previous diagnosis of stage I-III BC within the past 5 years
•No evidence of current, recurrent, or metastatic disease
•60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)
•Body mass index (BMI) >= 27 kg/m^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•Willingness to participate in all study activities
•Access to phone for study contacts
•Access to internet to participate in the online program and to be able to sync study devices
•Successful completion of at-home baseline assessments prior to randomization

排除标准

•Body mass index (BMI) < 27 kg/m^2 at time of baseline data collection
•Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
•Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
•Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine [T-DM1], trastuzumab deruxtecan [T-DXd])
•Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
•Pregnant, breastfeeding, or planning to become pregnant during the study period
•Use of exogenous hormones for gender affirmation
•For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months
•For stool sample collection only: Presence of self-reported ileostomy or colostomy
•For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
•Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.
•Concurrent enrollment in another weight loss or physical activity trial

研究组 & 干预措施

Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!

Experimental

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were responders (≥2% weight loss at 8 weeks).

In Stage 2, responders receive additional ¡Vida! intervention programming.

干预措施: ¡Vida! program (Behavioral)

Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus

Experimental

Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study.

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks).

In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL).

干预措施: ¡Vida! program (Behavioral)

Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus

Experimental

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks).

In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL).

干预措施: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] (Behavioral)

Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)

Experimental

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks).

In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.

干预措施: ¡Vida! program (Behavioral)

Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)

Experimental

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks).

In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.

干预措施: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] (Behavioral)

Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)

Experimental

This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks).

In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.

干预措施: Health Coaching (Behavioral)

Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus

Experimental

This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks).

In Stage 2, responders receive additional ¡Vida! Plus intervention programming.

干预措施: ¡Vida! program (Behavioral)

Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus

Experimental

This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks).

In Stage 2, responders receive additional ¡Vida! Plus intervention programming.

干预措施: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] (Behavioral)