Arthralgia, Breast Cancer
Conditions
Keywords
Aromatase inhibitor, Arthralgia Syndrome, Exercise
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.
Interventions
BEHAVIORALEducation 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.
BEHAVIORALEducation 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.
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | 3 months | 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. |
Countries
United States
Outcome results
None listed