Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376597
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2006-09-13
Brief Title:
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
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I II or III breast cancer who are undergoing axillary lymph node dissection surgery to remove lymph nodes found in the armpit region Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked damaged or removed by surgery A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection
Detailed Description:
OBJECTIVES
I To test in a group randomized controlled trial the efficacy of this program versus education only in reducing the incidence of lymphedema
II 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
III To assess the agreement between patients self-report of swelling mild moderate and severe and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference
IV To compare the health-related quality of life Factional Assessment of Cancer Therapy-Breast FACT-B4 score between the two interventions
V To characterize adherence to lymphedema prevention exercises lymphedema knowledge and range of motion
OUTLINE Patients are randomized to 1 of 2 arms
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 physical therapy intervention receive a refrigerator magnet and a 15-minute video that reinforces information and exercises
I To test in a group randomized controlled trial the efficacy of this program versus education only in reducing the incidence of lymphedema
II 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
III To assess the agreement between patients self-report of swelling mild moderate and severe and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference
IV To compare the health-related quality of life Factional Assessment of Cancer Therapy-Breast FACT-B4 score between the two interventions
V To characterize adherence to lymphedema prevention exercises lymphedema knowledge and range of motion
OUTLINE Patients are randomized to 1 of 2 arms
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 physical therapy intervention receive a refrigerator magnet and a 15-minute video that reinforces information and exercises
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA037447 | NIH | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA037447 |
| CDR0000494652 | REGISTRY | None | None |
| NCI-2009-00488 | REGISTRY | None | None |