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

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

Tracking Information

• First Submitted Date: September 13, 2006
• First Posted Date: September 15, 2006
• Results First Submitted Date: January 19, 2017
• Results First Posted Date: October 2, 2017
• Last Update Posted Date: February 7, 2019
• Actual Study Start Date: June 2006
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 29, 2017)

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

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

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: August 29, 2017)

• Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference [ Time Frame: 18 months ]
  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.
• 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 ]
  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.
• Health-related Quality of Life as Assessed by FACT-B +4 Score [ Time Frame: 18 months ]
  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.
• Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength [ Time Frame: from baseline up to 18 months ]
  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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Official Title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
• 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-B]+4 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Lymphedema

Intervention

• Other: quality of life assessment
  Ancillary studies
• Other: educational intervention
  Receive lymphedema educational materials
  Other Name: intervention, educational
• Procedure: Physical therapy
  Complete physical therapy-focused intervention
  Other Name: physiotherapy

Study Arms

• Experimental: 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.
  Interventions:

  • Other: quality of life assessment
  • Other: educational intervention
• Experimental: Arm II (lymphedema education, physical therapy)
  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.
  Interventions:

  • Other: quality of life assessment
  • Other: educational intervention
  • Procedure: Physical therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 29, 2017): 568
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 15, 2017
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Eligibility Criteria:

• Newly diagnosed with stage I-III cancer of the female breast

• No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), 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 cancer of the skin are eligible

• Neoadjuvant therapy

  • Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
  • Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
  • Patients receiving no neoadjuvant therapy are eligible
• May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study
• No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
• No diagnosed lymphedema
• In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
• Not currently homebound or dependent upon a walker or wheelchair for mobility
• Able to participate in a mild exercise program
• Willing to return to the study site for the duration of the study (18 months)
• Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)
• Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00376597
• 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alliance for Clinical Trials in Oncology
• Study Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Electra D. Paskett, PhD; Ohio State University Comprehensive Cancer Center

• PRS Account: Alliance for Clinical Trials in Oncology
• Verification Date: January 2019