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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

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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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
Enrollment 568
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description 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
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy) Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
554 patients were treated and analyzed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 242 participants 312 participants 554 participants
Female
242
 100.0%
312
 100.0%
554
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 242 participants 312 participants 554 participants
242 312 554
1.Primary Outcome
Title Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Hide Description To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
554 patients completed treatment and were analyzed.
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 242 312
Measure Type: Count of Participants
Unit of Measure: Participants
114
  47.1%
135
  43.3%
2.Secondary Outcome
Title Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Hide Description To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
402 patients were analyzed for this endpoint.
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 182 220
Mean (Standard Deviation)
Unit of Measure: cubic cm
55.1  (333.3) 46.6  (417.2)
3.Secondary Outcome
Title Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
Hide Description To assess the agreement between patients’ self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.
Arm/Group Title All Treated Patients
Hide Arm/Group Description:
This Arm consists of both Arm I and Arm II.
Overall Number of Participants Analyzed 368
Measure Type: Count of Participants
Unit of Measure: Participants
<0.5in difference between arms Number Analyzed 363 participants
Self Report None/Mild Swelling
353
  97.2%
Self Report Moderate swelling
8
   2.2%
Selft Report Severe swelling
2
   0.6%
0.5in - 2in difference between arms Number Analyzed 11 participants
Self Report None/Mild Swelling
11
 100.0%
Self Report Moderate swelling
0
   0.0%
Selft Report Severe swelling
0
   0.0%
>= 2in difference between arms Number Analyzed 2 participants
Self Report None/Mild Swelling
1
  50.0%
Self Report Moderate swelling
1
  50.0%
Selft Report Severe swelling
0
   0.0%
4.Secondary Outcome
Title Health-related Quality of Life as Assessed by FACT-B +4 Score
Hide Description To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
326 patients were analyzed for this measurement.
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 142 184
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (8.6) 0.1  (8.9)
5.Secondary Outcome
Title Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
Hide Description To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.
Time Frame from baseline up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
236 patients were analyzed for this endpoint.
Arm/Group Title Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 236
Measure Type: Count of Participants
Unit of Measure: Participants
6 months Number Analyzed 236 participants
>=75%
77
  32.6%
1%-74%
108
  45.8%
Not at all/never
51
  21.6%
12 months Number Analyzed 209 participants
>=75%
66
  31.6%
1%-74%
94
  45.0%
Not at all/never
49
  23.4%
18 months Number Analyzed 214 participants
>=75%
67
  31.3%
1%-74%
92
  43.0%
Not at all/never
55
  25.7%
Time Frame No adverse events were collected
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Hide Arm/Group Description 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.
All-Cause Mortality
Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Lymphedema Education) Arm II (Lymphedema Education, Physical Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Results Point of Contact
Name/Title: Electra D. Paskett, PhD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3917
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: February 7, 2019