跳至主要内容
临床试验/NCT04741802
NCT04741802已完成不适用

Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors

Duke University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Number of Women Who Attended the Information Session and Joined the TOPS Program

研究概览

简要总结

For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.

To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.

Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).

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
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

排除标准

  • Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.

结局指标

主要结局

Number of Women Who Attended the Information Session and Joined the TOPS Program

时间窗: One-time information session

Number of Women Who Remained in the Program for 24 Weeks

时间窗: up to 24 weeks

Measured by the number of women who reported to the 24-week weigh in.

Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session

时间窗: One-time invitation

Number of Women Who Remained in the Program for 12 Weeks

时间窗: up to 12 weeks

Measured by the number of women who reported to the 12-week weigh in.

次要结局

  • Percent Change in Participants' Weight as Measured by Scale Reading(baseline, 3 months, 6 months, 12 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验