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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Arthralgia
• Intervention / Treatment: Behavioral: Education and exercise intervention; Behavioral: Education and General Exercise

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20037
      • Victoria Shanmugam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Victoria K Shanmugam, MD, Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Aromatase inhibitor; Arthralgia Syndrome
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Joint Diseases; Musculoskeletal Diseases; Breast Neoplasms; Arthralgia
• Other Study ID Numbers: 2010-548