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

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
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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

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1. Primary:

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

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2. Secondary:

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

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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 ]

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4. Secondary:

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

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5. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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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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: 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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. 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