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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer |
- Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 560 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 76 Study Locations| Study Chair: | Electra D. Paskett, PhD | Ohio State University Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00376597 History of Changes |
| Other Study ID Numbers: | CDR0000494652, CALGB-70305 |
| Study First Received: | September 13, 2006 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
lymphedema perioperative/postoperative complications stage IA breast cancer stage IB breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Postoperative Complications Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013