Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection
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ClinicalTrials.gov Identifier: NCT00376597 |
Recruitment Status :
Completed
First Posted : September 15, 2006
Results First Posted : October 2, 2017
Last Update Posted : February 7, 2019
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Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
Condition |
Lymphedema |
Interventions |
Other: quality of life assessment Other: educational intervention Procedure: Physical therapy |
Enrollment | 568 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I (Lymphedema Education) | Arm II (Lymphedema Education, Physical Therapy) |
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Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months. | Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises. |
Period Title: Overall Study | ||
Started | 253 | 315 |
Completed | 242 | 312 |
Not Completed | 11 | 3 |
Baseline Characteristics
Arm/Group Title | Arm I (Lymphedema Education) | Arm II (Lymphedema Education, Physical Therapy) | Total | |
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Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months. | Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises. | Total of all reporting groups | |
Overall Number of Baseline Participants | 242 | 312 | 554 | |
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554 patients were treated and analyzed.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 242 participants | 312 participants | 554 participants | |
57.9 (11.4) | 57.5 (11.2) | 57.7 (11.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 242 participants | 312 participants | 554 participants | |
Female |
242 100.0%
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312 100.0%
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554 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 242 participants | 312 participants | 554 participants |
242 | 312 | 554 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Electra D. Paskett, PhD |
Organization: | The Ohio State University Comprehensive Cancer Center |
Phone: | 614-293-3917 |
EMail: | electra.paskett@osumc.edu |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00376597 |
Other Study ID Numbers: |
CALGB-70305 CDR0000494652 ( Registry Identifier: NCI Physician Data Query ) NCI-2009-00488 ( Registry Identifier: NCI Clinical Trial Reporting Program ) U10CA037447 ( U.S. NIH Grant/Contract ) |
First Submitted: | September 13, 2006 |
First Posted: | September 15, 2006 |
Results First Submitted: | January 19, 2017 |
Results First Posted: | October 2, 2017 |
Last Update Posted: | February 7, 2019 |