Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Accrual rate
研究概览
简要总结
The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment
- •No evidence of recurrent or metastatic disease
- •No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 8%
- •No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care
- •At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
- •Access to phone for study contacts
- •Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website)
- •Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months
- •Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample
- •Willing and able to complete all study activities for 6 months after randomization
- •Participants must consume < 5 servings of fruits and vegetables per day and/or engage in < 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status.
- •Signed physician approval for diet change and physical activity
- •Able to understand and willing to sign written informed electronic (e) consent in English
排除标准
- •Participants must not be active smokers within the past 30 days.
- •Women must not be pregnant at time of enrollment
研究组 & 干预措施
Arm A (low dose nutrition and PA class, eHealth intervention)
Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: One Diet and Physical Activity Session (Behavioral)
Arm A (low dose nutrition and PA class, eHealth intervention)
Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Electronic (e) Health (eHealth) Communication Intervention (Other)
Arm A (low dose nutrition and PA class, eHealth intervention)
Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Questionnaire Administration (Other)
Arm A (low dose nutrition and PA class, eHealth intervention)
Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Quality-of-Life Assessment (Other)
Arm B (high dose nutrition and PA class, eHealth intervention)
Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Electronic (e) Health (eHealth) Communication Intervention (Other)
Arm B (high dose nutrition and PA class, eHealth intervention)
Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Twelve Diet and Physical Activity Group Sessions (Behavioral)
Arm B (high dose nutrition and PA class, eHealth intervention)
Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Questionnaire Administration (Other)
Arm B (high dose nutrition and PA class, eHealth intervention)
Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Accrual rate
时间窗: At 6 months
Accrual rate will be measured by number of participants randomized during each month of study accrual.
Adherence: Responsiveness to eHealth communication
时间窗: At 6 months
Adherence will be measured by the number of responses to text messages per participant.
Biospecimen collection rate
时间窗: At 6 months
Biospecimen collection rate will be assessed based on number of biospecimens collected.
Retention
时间窗: At 6 months
Retention will be measured by the number of completed study assessments per participants.
Acceptability: Questions during exit interview
时间窗: At 6 months
Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.
Adherence: Session(s) Attendance
时间窗: At 6 months
Adherence will be measured by number of online session(s) attended per participant.
次要结局
- Change in daily servings of fruits and vegetables per day(Baseline to 6 months)
- Change in minutes per week of moderate-to-vigorous physical activity(Baseline to 6 months)
- Change in systemic inflammation(Baseline to 6 months)
- Change in gut barrier permeability(Baseline to 6 months)