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

Not Applicable

Terminated

• Conditions: Arthralgia; Breast Cancer
• Interventions: Behavioral: Education and exercise intervention; Behavioral: Education and General Exercise

• Registration Number: NCT01351844
• Lead Sponsor: George Washington University

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 Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education and exercise intervention	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.
Education and general exercise	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	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.

Secondary Outcome Measures

Name	Time	Method
Grip Strength	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.

Trial Locations

Locations (1)

Victoria Shanmugam; 🇺🇸 Washington, D.C., District of Columbia, United States