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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Fatigue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Participant are randomized after receiving an exercise recommendation by their oncologist and thus oncologists are masked; however, study staff will administer survey questions including acceptability of the DVD and thus outcomes assessors are not masked
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not medically cleared to participate in low-intensity exercise
研究组 & 干预措施
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.
干预措施: Oncologist Recommendation (Behavioral)
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.
干预措施: Oncologist Recommendation + DVD (Behavioral)
结局指标
主要结局
Change in Patient-Reported Fatigue
时间窗: baseline, 4 and 8 weeks
Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
次要结局
- Change in self-efficacy for exercise(baseline, 4 and 8 weeks)
- Change in exercise readiness assessed by the Stage of Change for exercise(baseline, 4 and 8 weeks)
- Change in self-report physical activity measured with the International Physical Activity Questionnaire(Baseline, 4 and 8 weeks)
研究者
Kerri Winters
Research Professor
Oregon Health and Science University
