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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

May 10, 2011
May 29, 2012
May 2011
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01351844 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Breast Cancer
  • Arthralgia
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Education and exercise intervention
  • 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.
    Intervention: Behavioral: Education and General Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Victoria K Shanmugam, MD 202-444-6200 vks4@gunet.georgetown.edu
Contact: Sean McNish 202-444-6200 sm965@georgetown.edu
United States
 
NCT01351844
2010-548
No
Vicki Shanmugam, Georgetown University
Georgetown University
Not Provided
Principal Investigator: Victoria K Shanmugam, MD Georgetown University Hospital
Georgetown University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP