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Exercise Information for Women With Cancer

2017年4月14日 更新者:Kerri Winters、Oregon Health and Science University

A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients

Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study will determine whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.

研究概览

详细说明

Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).

Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.

研究类型

介入性

注册 (实际的)

95

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Oregon
      • Portland、Oregon、美国、97239
        • OHSU School of Nursing

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Diagnosis of breast cancer
  • Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health & Science University (OHSU)
  • Capable of answering survey questions by phone

Exclusion Criteria:

  • Not medically cleared to participate in low-intensity exercise

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Oncologist Recommendation only
Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit. Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials. The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS). The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services.
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
实验性的:Oncologist Recommendation + DVD
Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD. Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation. The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist. The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease. Women are encouraged to use the DVD at least 3 times per week.
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Patient-Reported Fatigue
大体时间:baseline, 4 and 8 weeks
Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
baseline, 4 and 8 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in self-efficacy for exercise
大体时间:baseline, 4 and 8 weeks
Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise
baseline, 4 and 8 weeks
Change in exercise readiness assessed by the Stage of Change for exercise
大体时间:baseline, 4 and 8 weeks
We will measure a person's readiness to engage in recommended levels of physical activity using the Stage of Change for behavior change modified for exercise
baseline, 4 and 8 weeks
Change in self-report physical activity measured with the International Physical Activity Questionnaire
大体时间:Baseline, 4 and 8 weeks
We will measure changes in the reported time spent in physical activities per week
Baseline, 4 and 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年8月1日

初级完成 (实际的)

2011年7月31日

研究完成 (实际的)

2017年4月1日

研究注册日期

首次提交

2017年4月12日

首先提交符合 QC 标准的

2017年4月14日

首次发布 (实际的)

2017年4月19日

研究记录更新

最后更新发布 (实际的)

2017年4月19日

上次提交的符合 QC 标准的更新

2017年4月14日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00005997

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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