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

This study is currently recruiting participants.
Verified May 2012 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Vicki Shanmugam, Georgetown University
ClinicalTrials.gov Identifier:
NCT01351844
First received: May 10, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Breast Cancer
Arthralgia
 Behavioral: Education and exercise intervention
Behavioral: Education and General Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351844

Contacts
Contact: Victoria K Shanmugam, MD 202-444-6200 vks4@gunet.georgetown.edu
Contact: Sean McNish 202-444-6200 sm965@georgetown.edu

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Victoria K Shanmugam, MD     202-444-6200     vks4@gunet.georgetown.edu    
Contact: Sean McNish     202-444-6200     sm965@georgetown.edu    
Principal Investigator: Victoria K Shanmugam, MD            
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Victoria K Shanmugam, MD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Vicki Shanmugam, Assistant Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT01351844     History of Changes
Other Study ID Numbers: 2010-548
Study First Received: May 10, 2011
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Aromatase inhibitor
Arthralgia Syndrome
Exercise

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013