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

Breast Cancer Clinical Trial

— CEASE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01351844
• Other study ID #: 2010-548
• Status: Terminated
• Phase: N/A
• First received: May 10, 2011
• Last updated: August 28, 2017
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2017
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Education and exercise intervention
An occupational therapist who has clinical experience in hand therapy for breast cancer patients with arthralgia syndrome, will review 4-5 exercises which improve hand range of motion and reduce hand stiffness.
• Education and General Exercise
A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.

Locations

Country	Name	City	State
United States	Victoria Shanmugam	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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.	3 months
Secondary	Grip Strength	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.	3 months