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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376597
First Posted: September 15, 2006
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: January 19, 2017  
Study Type: Interventional
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I (Lymphedema Education) 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.
Arm II (Lymphedema Education, Physical Therapy) 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.

Participant Flow:   Overall Study
    Arm I (Lymphedema Education)   Arm II (Lymphedema Education, Physical Therapy)
STARTED   253   315 
COMPLETED   242   312 
NOT COMPLETED   11   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
554 patients were treated and analyzed.

Reporting Groups
  Description
Arm I (Lymphedema Education) 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.
Arm II (Lymphedema Education, Physical Therapy) 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 Total of all reporting groups

Baseline Measures
   Arm I (Lymphedema Education)   Arm II (Lymphedema Education, Physical Therapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 242   312   554 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.9  (11.4)   57.5  (11.2)   57.7  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      242 100.0%      312 100.0%      554 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   242   312   554 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Were Lymphedema-free 18 Months After Randomization   [ Time Frame: 18 months ]

2.  Secondary:   Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference   [ Time Frame: 18 months ]

3.  Secondary:   Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm   [ Time Frame: 18 months ]

4.  Secondary:   Health-related Quality of Life as Assessed by FACT-B +4 Score   [ Time Frame: 18 months ]

5.  Secondary:   Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength   [ Time Frame: from baseline up to 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Electra D. Paskett, PhD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3917
e-mail: electra.paskett@osumc.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00376597     History of Changes
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: October 2, 2017