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

Primary Purpose

Breast Cancer, Arthralgia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and exercise intervention
Education and General Exercise
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Aromatase inhibitor, Arthralgia Syndrome, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Victoria Shanmugam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Education and exercise intervention

Education and general exercise

Arm Description

The "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2011
Last Updated
August 28, 2017
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT01351844
Brief Title
The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Acronym
CEASE
Official Title
Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit sufficient patients
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Arthralgia
Keywords
Aromatase inhibitor, Arthralgia Syndrome, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education and exercise intervention
Arm Type
Active Comparator
Arm Description
The "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises.
Arm Title
Education and general exercise
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Education and exercise intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education and General Exercise
Intervention Description
A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.
Primary Outcome Measure Information:
Title
Feasibility
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Grip Strength
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria K Shanmugam, MD
Organizational Affiliation
Georgetown University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Shanmugam
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

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

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