Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.
详细描述
Primary Objective:
Assess the feasibility of delivering the ACLP, ACLP-LC, and ACLP-LC-IHC programs in stable HR+/HER2- MBC survivors. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 50% of those randomized remaining in the study and who participated in at least 75% of online sessions). Our working hypothesis is that the provision of the evidence-based, mHeath ACLP with the Learning Circle support group, with or without individual health coaching, is feasible in patients with stable HR+/HER2- MBC.
Secondary Objectives:
- Explore changes in targeted health behaviors of diet, exercise, and stress management.
- Examine changes in patient-reported outcomes (PROs), including: QOL, fatigue, sleep disturbances, mental health, social support, mindfulness, and stages of change.
- Examine if there are group differences in post-intervention albumin, vit D, and magnesium levels.
OUTLINE: Patients are first randomized to 1 of 3 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients with HR+/HER2 negative MBC
- •On first- or second-line treatment
- •Life expectancy at least 12 months
- •Only females
- •Age 18 years or older
- •Able to read, write, and speak English
- •Willingness to follow protocol requirements
- •Have a smartphone with access to cellular service or computer access with internet service
- •Oriented to person, place, and time
- •Consume less than 3 servings of fruit and vegetable/day
- •Engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
- •Engage in a mind-body practice less than 4 times a month
排除标准
- •Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
- •Any major thought disorder (e.g., schizophrenia, dementia)
- •Communication barriers (e.g., hard of hearing)
- •Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)
- •Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
研究组 & 干预措施
ACLP Program
Participants will take part in the ACLP alone
干预措施: Demographics/Lifestyle Survey (Other)
ACLP Program + Learning Circles
Participants will take part in the ACLP and Learning Circles
干预措施: Demographics/Lifestyle Survey (Other)
ACLP Program + Learning Circles + Individual Health Coaching
Participants will take part in the ACLP and in Learning Circles After participants complete the ACLP with Learning Circles, they will receive up to 6 individualized health coaching sessions.
干预措施: Demographics/Lifestyle Survey (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点