Clinical Trial: The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

Brief Summary: 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.

Detailed Summary:
Sponsor: Georgetown University

Current Primary Outcome: Feasibility [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Grip Strength [ Time Frame: 3 months ]

The impact of the exercise education on symptoms will be assessed using grip strength evaluation with dynamometer at the baseline and three month follow-up visits, along with standardized pain and quality of life questionnaires completed at both time points.


Original Secondary Outcome: Same as current

Information By: Georgetown University

Dates:
Date Received: May 10, 2011
Date Started: May 2011
Date Completion:
Last Updated: August 6, 2013
Last Verified: August 2013