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临床试验/NCT01728506
NCT01728506Unknown不适用

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program

University of Vermont3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
48
试验地点
3
主要终点
Change in anthropometric measures

研究概览

简要总结

The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.

This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.

Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.

Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.

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 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •breast cancer diagnosis
  • •Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast cancer 2-12 months prior to study initiation
  • •BMI between 27 and 50
  • •patient self-report of ability to walk for 10 minutes without interruption or pain
  • •access to computer and the internet

排除标准

  • •metastatic disease
  • •prior receipt of chemotherapy for other malignancy
  • •pregnancy at the time of study entry
  • •limited food choices due to celiac sprue or inflammatory bowel disease
  • •illiteracy
  • •non-English speaking

研究组 & 干预措施

Weight Loss & Exercise

Experimental

Single arm intervention of a 24 week weight loss and exercise intervention.

干预措施: Weight Loss and Exercise (Behavioral)

结局指标

主要结局

Change in anthropometric measures

时间窗: Change from baseline anthropometrics at 6 months

Change in Weight, BMI, body fat percentage before and after the intervention

Change in active energy expenditure (ie exercise)

时间窗: Change from baseline active energy expenditure at 6 months

exercise will be measured using an accelerometer before and after the intervention

Feasibility

时间窗: Change from baseline fesability at 6 months

Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.

Change in diet measures

时间窗: Change from baseline diet measures at 6 months

Efficacy will be measured using total calories and fat grams before and after the intervention

次要结局

  • Change in inflammatory biomarkers(Change from baseline inflammatory biomarkers at 6 months)
  • Change in insulin resistance markers(Change from baseline insulin resistance markers at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kim Dittus

Assistant Professor

University of Vermont

研究点 (3)

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