- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00376597
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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California
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Castro Valley, California, Förenta staterna, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Förenta staterna, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, Förenta staterna, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Förenta staterna, 94538
- Valley Medical Oncology
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Martinez, California, Förenta staterna, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Förenta staterna, 94040
- El Camino Hospital Cancer Center
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Oakland, California, Förenta staterna, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Förenta staterna, 94602
- Highland General Hospital
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Oakland, California, Förenta staterna, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Förenta staterna, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Förenta staterna, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Förenta staterna, 94609
- Tom K Lee, Incorporated
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San Pablo, California, Förenta staterna, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, Förenta staterna, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, Förenta staterna, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, Förenta staterna, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Förenta staterna, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Förenta staterna, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Deerfield Beach, Florida, Förenta staterna, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, Förenta staterna, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Förenta staterna, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, Förenta staterna, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, Förenta staterna, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Förenta staterna, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, Förenta staterna, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, Förenta staterna, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, Förenta staterna, 61265
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Moline, Illinois, Förenta staterna, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, Förenta staterna, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Förenta staterna, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Förenta staterna, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Förenta staterna, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Förenta staterna, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, Förenta staterna, 52722
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Förenta staterna, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Förenta staterna, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Förenta staterna, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503-9985
- Central Baptist Hospital
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Maine
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York, Maine, Förenta staterna, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton, Maryland, Förenta staterna, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, Förenta staterna, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, Förenta staterna, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, Förenta staterna, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, Förenta staterna, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, Förenta staterna, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees, New Jersey, Förenta staterna, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, Förenta staterna, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, Förenta staterna, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Tennessee
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Cookeville, Tennessee, Förenta staterna, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, Förenta staterna, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Förenta staterna, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, Förenta staterna, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, Förenta staterna, 22102
- Kaiser Permanente Tysons Corner Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Ancillary studies
Receive lymphedema educational materials
Andra namn:
|
Experimentell: 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.
|
Ancillary studies
Receive lymphedema educational materials
Andra namn:
Complete physical therapy-focused intervention
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Tidsram: 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
|
18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Tidsram: 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.
|
18 months
|
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
Tidsram: 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.
|
18 months
|
Health-related Quality of Life as Assessed by FACT-B +4 Score
Tidsram: 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.
|
18 months
|
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
Tidsram: 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.
|
from baseline up to 18 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publikationer och användbara länkar
Allmänna publikationer
- Paskett ED, Le-Rademacher J, Oliveri JM, Liu H, Seisler DK, Sloan JA, Armer JM, Naughton MJ, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C. A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance). Cancer. 2021 Jan 15;127(2):291-299. doi: 10.1002/cncr.33183. Epub 2020 Oct 20.
- Naughton MJ, Liu H, Seisler DK, Le-Rademacher J, Armer JM, Oliveri JM, Sloan JA, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C, Paskett ED. Health-related quality of life outcomes for the LEAP study-CALGB 70305 (Alliance): A lymphedema prevention intervention trial for newly diagnosed breast cancer patients. Cancer. 2021 Jan 15;127(2):300-309. doi: 10.1002/cncr.33184. Epub 2020 Oct 20.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CALGB-70305
- U10CA037447 (U.S.S. NIH-anslag/kontrakt)
- CDR0000494652 (Registeridentifierare: NCI Physician Data Query)
- NCI-2009-00488 (Registeridentifierare: NCI Clinical Trial Reporting Program)
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