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临床试验/NCT02387671
NCT02387671已完成不适用

Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Body Weight

研究概览

简要总结

The long-term goal of this research is to develop, evaluate and implement effective mHealth technology interventions that improve cancer management outcomes by changing lifestyle behaviors among urban health- disparity facing populations. To accomplish this goal, the investigators will need to determine the feasibility and preliminary efficacy of an intervention in which breast cancer survivors receive counseling about lifestyle behaviors (weight, nutrition, and physical activity) from a health counselor trained in evidenced-based behavioral counseling methods.

详细描述

Tremendous advances in detection and treatment of breast cancer have led to an increasingly large cohort of survivors focused on health promotion and reducing the risk of recurrence. While adjuvant therapy, such as hormone therapy, is often used to prevent cancer recurrence, modification of lifestyle is an effective tool to increase quality of life, prevent future cancer recurrence and increase long-term health. However, translating these recommendations into population-wide, inexpensive, sustainable programs for cancer survivors has to date proven largely unrealized. These programs are particularly needed in health disparity-facing populations (i.e., low socio-economic status and/or racial/ethnic minority groups) due to the high burden of cancer incidence and mortality they face. Limited translation is due to many factors including the complexity of lifestyle habits, high patient burden of many behavioral interventions, low levels of engagement and adherence to interventions, and the lack of integration of behavior change tools into daily lifestyles. In this context, there is great promise of tools that are mobile, simple, and embedded into daily life routines. The long-term goal of this research program is to develop, evaluate and implement effective mHealth technology interventions that improve cancer management outcomes by changing lifestyle behaviors among urban health- disparity facing populations.

The mHealth intervention for cancer survivors devised by the investigators consists of several components: 1) a commercially available smart phone app that captures patients' behavioral data (steps, sleep, weight) using devices (a FitBit and a FitBit scale), 2) text messages to participants to collect additional data (foods eaten, eating habits), and 3) phone sessions with a non-professionally trained health counselor about diet and physical activity behaviors.

The investigators propose to test the feasibility and preliminary outcomes on weight, behaviors, psychological factors as well as participant engagement in the intervention of our mHealth counseling intervention among 20 breast cancer survivors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Willing to participate in intervention by sharing FitBit account information (log in/password) with study team
  • 6 months or more since receiving cancer treatment including surgery, radiation, or chemotherapy (self-reported)
  • 2 or more years post breast cancer diagnosis (self-reported)
  • Current ownership of an iOS or Android based platform smartphone and home wifi
  • Age 18 and above
  • Ability to speak and read in English
  • Overweight or obese (body mass index ≥ 25)

排除标准

  • Medical conditions including dementia, active cancer, anorexia or any other condition in the opinion of the investigator makes the participant unsuitable for inclusion in the study
  • Presence of a pacemaker or other internal medical device
  • Those with contraindications for physical activity
  • Pregnant women
  • Inability to easily navigate programs on a smartphone

结局指标

主要结局

Body Weight

时间窗: 8 weeks

Participants will register daily body weight measurements during the 8-week study period. Weight will be recorded in units of pounds using the FitBit wifi compatable. All data will be synced to the participants' FitBit account and monitored by the study team.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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