Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Post-menopausal stage I-III breast cancer patients
- •Starting or about to start aromatase inhibitor
- •English speaking with ability to read, write and use a computer to watch and listen to an educational module.
- •Able to give informed consent
排除标准
- •Aromatase inhibitor (AI) use for more than 6 months
- •Metastatic breast cancer
- •Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
- •Unable to give informed consent
研究组 & 干预措施
Education and exercise intervention
The "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises.
干预措施: Education and exercise intervention (Behavioral)
Education and general exercise
The "control" module will contain a brief series of slides with a voice-over. A physical therapist with experience in treating breast cancer patients will demonstrate a series of 4-5 general stretching and toning exercises.
干预措施: Education and General Exercise (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 3 months
This study is designed as a pilot study to assess feasibility of this educational intervention in a small population of only 40 patients. Patients will be given the option to complete the module from home. The primary endpoint will be patient completion of the educational module and follow-up questionnaires.
次要结局
- Grip Strength(3 months)
研究者
Victoria Shanmugam
Associate Professor of Medicine
George Washington University