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 currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376597
First received: September 13, 2006
Last updated: December 19, 2012
Last verified: December 2012

September 13, 2006
December 19, 2012
June 2006
December 2012   (final data collection date for primary outcome measure)
Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00376597 on ClinicalTrials.gov Archive Site
  • Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ]
  • Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ]
  • Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ]
  • Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ]
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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
A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.

OBJECTIVES:

Primary

  • Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Secondary

  • Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.
  • Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).
  • Compare the health-related quality of life of these patients.
  • Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.

OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.

All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection.

  • Arm I: 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: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Supportive Care
  • Breast Cancer
  • Lymphedema
  • Perioperative/Postoperative Complications
  • Behavioral: exercise intervention
  • Other: educational intervention
  • Procedure: assessment of therapy complications
  • Procedure: complementary or alternative medicine procedure
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
Not Provided
December 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Newly diagnosed disease
    • Stage I-III disease
  • No diagnosed lymphedema
  • Must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of six sleeve sizes (i.e., all three measurments must be found in one column) available
  • Scheduled to undergo axillary node dissection with ≥ 10 nodes removed

    • No sentinel axillary node dissection only
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly increases mortality over the next 2 years
  • May not be currently homebound or dependent upon a walker or wheelchair for mobility
  • Able to participate in a mild exercise program
  • No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer

    • Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis
    • Patients with basal cell and squamous cell carcinoma of the skin are eligible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms

    • Prior treatment (i.e., surgergy and/or radiotherapy) on the contralateral arm allowed provided it is documented appropriately
  • May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection

    • Patients enrolled on ACOSOG-Z1071 allowed
  • Any type of radiotherapy to the breast or axilla allowed
  • Neoadjuvant treatment for this cancer allowed
Female
18 Years and older
No
United States
 
NCT00376597
CDR0000494652, CALGB-70305
Not Provided
Not Provided
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Electra D. Paskett, PhD Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP