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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Arthralgia

Intervention / Treatment
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* Behavioral: Education and exercise intervention
* Behavioral: Education and General Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education and exercise intervention<br>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<br>* 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.<br>|
| Placebo Comparator: Education and general exercise<br>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<br>* A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatase inhibitor, Arthralgia Syndrome, Exercise