A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life.
Participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.
详细描述
The study will include 45 subjects recruited from AdventHealth Medical Group in the HEAL Breast Cancer Program that consent to participate in the research study. The research study will include data collection along with the program participation. Patients who decline participation in the research study are able to participate in the HEAL Breast Cancer Program. The program sessions will be conducted virtually via Zoom by Dr. Amber Orman, a breast cancer physician board certified in radiation oncology and lifestyle medicine. There are eight program sessions, one per week, each lasting 90-minutes. The survey package includes nine questionnaires and is expected to take 60 minutes to complete.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years old
- •Diagnosis of breast cancer
- •Enrolled in the HEAL: Breast Cancer Program
- •Able to speak, read, and understand English fluently
- •Willing and able to provide informed consent
- •Willing and able to comply with all study procedures and requirements for the duration of the study
排除标准
- •Not willing or able to provide informed consent
- •Not willing or able to comply with all study procedures and requirements for the duration of the study
结局指标
主要结局
Perceived Stress Scale
时间窗: Baseline, Week 8, 3-month follow up, 6-month follow up
PSS-10 is a ten item questionnaire covering the last month using 5 point Likert scale with 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Fairly often, 4 = Very often.
次要结局
- mini-Eating Assessment Tool (mini-EAT)(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Comprehensive metabolic panel(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Hemoglobin A1C(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Weight(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Generalized Anxiety Disorder - 2 item scale(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Patient Health Questionnaire - 2 item(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Functional Assessment of Cancer Therapy - General - 7-item version(Baseline, Week 8, 3-month follow up, 6-month follow up)
- General Self-Efficacy Scale(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Body Mass Index(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Blood pressure(Baseline, Week 8, 3-month follow up, 6-month follow up)
- Lipid panel(Baseline, Week 8, 3-month follow up, 6-month follow up)