The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer (CEASE)
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|ClinicalTrials.gov Identifier: NCT01351844|
Recruitment Status : Terminated (Unable to recruit sufficient patients)
First Posted : May 11, 2011
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Arthralgia||Behavioral: Education and exercise intervention Behavioral: Education and General Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
- Feasibility [ Time Frame: 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.
- Grip Strength [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351844
|United States, District of Columbia|
|Washington, D.C., District of Columbia, United States, 20037|
|Principal Investigator:||Victoria K Shanmugam, MD||Georgetown University Hospital|