The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
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.
|
| Placebo Comparator: 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Post-menopausal stage I-III breast cancer patients
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Starting or about to start aromatase inhibitor
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English speaking with ability to read, write and use a computer to watch and listen to an educational module.
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Able to give informed consent
Exclusion Criteria:
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Aromatase inhibitor (AI) use for more than 6 months
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Metastatic breast cancer
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Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
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Unable to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Victoria Shanmugam | Washington, D.C. | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- George Washington University
Investigators
- Principal Investigator: Victoria K Shanmugam, MD, Georgetown University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-548