Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
研究概览
简要总结
This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.
详细描述
More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40-70 years of age
- •History of breast cancer stage I-II
- •2-10 years post-treatment
- •Sedentary
- •Technology access and skills
- •Regular access to personal computer/ broadband internet and email account
- •Comfortability using internet, and web-based tools
- •US Resident
排除标准
- •Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
- •Current secondary cancer diagnosis/ treatment
- •Inability to ambulate
- •Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
- •Engaging in regular moderate to vigorous physical activity
结局指标
主要结局
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
时间窗: 12 weeks
The primary outcome will be measured using weekly step data as measured by a commercially available accelerometer. The primary outcome will be the difference in weekly steps between the intervention and comparison group at the end of the intervention (week 12).
次要结局
未报告次要终点
研究者
Leanne Kaye
Doctoral Candidate
UNC Lineberger Comprehensive Cancer Center