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

George Washington University (GW)

Status: Terminated

Conditions: Breast Cancer; Arthralgia

Treatments: Behavioral: Education and General Exercise; Behavioral: Education and exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01351844

2010-548

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

12 participants in 2 patient groups, including a placebo group

Education and exercise intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Education and exercise intervention

Education and general exercise

Placebo Comparator group

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.

Treatment:

Behavioral: Education and General Exercise