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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Arthralgia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Feasibility

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Victoria K Shanmugam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University Hospital

Authority:

United States: Institutional Review Board

Study ID:

2010-548

NCT ID:

NCT01351844

Start Date:

May 2011

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • Arthralgia
  • Aromatase inhibitor
  • Arthralgia Syndrome
  • Exercise
  • Arthralgia
  • Breast Neoplasms

Name

Location

Georgetown University Hospital Washington, District of Columbia  20007