Trial Outcomes & Findings for 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 (NCT NCT00376597)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

568 participants

Primary outcome timeframe

18 months

Results posted on

2019-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	253	315
Overall Study COMPLETED	242	312
Overall Study NOT COMPLETED	11	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Lymphedema Education) n=242 Participants 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) n=312 Participants 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 n=554 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.5 years STANDARD_DEVIATION 11.2 • n=7 Participants	57.7 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	242 Participants n=5 Participants	312 Participants n=7 Participants	554 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	242 participants n=5 Participants	312 participants n=7 Participants	554 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: 554 patients completed treatment and were analyzed.

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

Outcome measures

Outcome measures
Measure	Arm I (Lymphedema Education) n=242 Participants 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) n=312 Participants 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.
Number of Participants Who Were Lymphedema-free 18 Months After Randomization	114 Participants	135 Participants

SECONDARY outcome

Timeframe: 18 months

Population: 402 patients were analyzed for this endpoint.

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.

Outcome measures

Outcome measures
Measure	Arm I (Lymphedema Education) n=182 Participants 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) n=220 Participants 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.
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference	55.1 cubic cm Standard Deviation 333.3	46.6 cubic cm Standard Deviation 417.2

SECONDARY outcome

Timeframe: 18 months

Population: 368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.

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.

Outcome measures

Outcome measures
Measure	Arm I (Lymphedema Education) n=368 Participants 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.
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm 0.5in - 2in difference between arms · Selft Report Severe swelling	0 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm <0.5in difference between arms · Self Report None/Mild Swelling	353 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm <0.5in difference between arms · Self Report Moderate swelling	8 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm <0.5in difference between arms · Selft Report Severe swelling	2 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm 0.5in - 2in difference between arms · Self Report None/Mild Swelling	11 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm 0.5in - 2in difference between arms · Self Report Moderate swelling	0 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm >= 2in difference between arms · Self Report None/Mild Swelling	1 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm >= 2in difference between arms · Self Report Moderate swelling	1 Participants	—
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm >= 2in difference between arms · Selft Report Severe swelling	0 Participants	—

SECONDARY outcome

Timeframe: 18 months

Population: 326 patients were analyzed for this measurement.

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.

Outcome measures

Outcome measures
Measure	Arm I (Lymphedema Education) n=142 Participants 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) n=184 Participants 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.
Health-related Quality of Life as Assessed by FACT-B +4 Score	1.4 Units on a scale Standard Deviation 8.6	0.1 Units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: from baseline up to 18 months

Population: 236 patients were analyzed for this endpoint.

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.

Outcome measures

Outcome measures
Measure	Arm I (Lymphedema Education) n=236 Participants 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.
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 12 months · >=75%	66 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 12 months · 1%-74%	94 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 12 months · Not at all/never	49 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 18 months · >=75%	67 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 18 months · 1%-74%	92 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 18 months · Not at all/never	55 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 6 months · >=75%	77 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 6 months · 1%-74%	108 Participants	—
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength 6 months · Not at all/never	51 Participants	—

Adverse Events

Arm I (Lymphedema Education)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Lymphedema Education, Physical Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Electra D. Paskett, PhD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60