Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of invitations sent through the electronic health record to get 25 individuals consented to the study
研究概览
简要总结
The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.
The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.
This ClinicalTrials.gov record is specific to the second part of the study.
详细描述
The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.
The information gathered from these groups will be used to improve the materials which lead to part two of the study.
The second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.
For the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aim 2 Inclusion Criteria:
- •women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).
排除标准
- •Those whose oncology providers do not agree with their participation in a weight loss program
- •History of Type II Diabetes Mellitus
- •those participating in another weight loss program
- •those taking a weight loss medication
- •those without smart phones or internet connections or the ability to attend meetings via Zoom
研究组 & 干预措施
TOPS Classes
干预措施: TOPS Classes (Other)
结局指标
主要结局
Number of invitations sent through the electronic health record to get 25 individuals consented to the study
时间窗: 1-2 months
Percentage of TOPS group session attendance
时间窗: 12 months
This will be calculated as number of sessions attended divided by total number of sessions offered
Number of participants who stay in the study
时间窗: 3 months, 6 months, 9 months, 12 months
Number of participants who transition from the initiation phase to the maintenance phase
时间窗: 12 months
Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase
时间窗: 9 months, 12 months
Percent of Weight Loss
时间窗: Up to 12 Months
次要结局
- Quality of Life (QOL) as measured by survey(up to 12 months)
- Cardiovascular Disease (CVD) risk factors as measured by glucose(up to 12 months)
- Percentage of participants who get blood drawn(Baseline, 3 months, 6 months,12 months)
- Cardiovascular Disease (CVD) risk factors as measured by blood pressure(up to 12 months)
- Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c(up to 12 months)