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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

22. januar 2019 opdateret af: Alliance for Clinical Trials in Oncology

A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

568

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Concord, California, Forenede Stater, 94524-4110
        • Cancer Care Center at John Muir Health - Concord Campus
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital Cancer Center
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee, Incorporated
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center - San Pablo Campus
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
        • St. Vincent's Medical Center
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Forenede Stater, 20002
        • Kaiser Permanente at Capitol Hill Medical Center
    • Florida
      • Deerfield Beach, Florida, Forenede Stater, 33064-3596
        • North Broward Medical Center
      • Jupiter, Florida, Forenede Stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • CCOP - Mount Sinai Medical Center
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Memorial Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60631
        • Resurrection Medical Center
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • Alexian Brothers Radiation Oncology
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Moline, Illinois, Forenede Stater, 61265
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Forenede Stater, 46601
        • Michiana Hematology-Oncology, PC - South Bend
    • Iowa
      • Bettendorf, Iowa, Forenede Stater, 52722
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas, PA - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503-9985
        • Central Baptist Hospital
    • Maine
      • York, Maine, Forenede Stater, 03909
        • York Hospital's Oncology Treatment Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21244
        • Kaiser Permanente at Woodlawn Medical Center
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
      • Gaithersburg, Maryland, Forenede Stater, 20879
        • Kaiser Permanente - Gaithersburg Medical Center
      • Largo, Maryland, Forenede Stater, 20774
        • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
      • Silver Spring, Maryland, Forenede Stater, 20910
        • Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center Cancer Center
      • Hyannis, Massachusetts, Forenede Stater, 02601
        • Cape Cod Hospital
    • New Jersey
      • Elizabeth, New Jersey, Forenede Stater, 07207
        • Trinitas Comprehensive Cancer Center at Trinitas Hospital
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Staten Island, New York, Forenede Stater, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • Leo W. Jenkins Cancer Center at ECU Medical School
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    • Tennessee
      • Cookeville, Tennessee, Forenede Stater, 38501
        • Cookeville Regional Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Laredo, Texas, Forenede Stater, 78045
        • Doctor's Hospital of Laredo
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22033
        • Kaiser Permanente Medical Center - Fair Oaks
      • McLean, Virginia, Forenede Stater, 22102
        • Kaiser Permanente Tysons Corner Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: quality of life assessment
Ancillary studies
Andet: educational intervention
Receive lymphedema educational materials
Andre navne:
  • intervention, pædagogisk
Eksperimentel: 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.
Andet: quality of life assessment
Ancillary studies
Andet: educational intervention
Receive lymphedema educational materials
Andre navne:
  • intervention, pædagogisk
Procedure: Physical therapy
Complete physical therapy-focused intervention
Andre navne:
  • fysioterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2006

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

15. juni 2017

Datoer for studieregistrering

Først indsendt

13. september 2006

Først indsendt, der opfyldte QC-kriterier

13. september 2006

Først opslået (Skøn)

15. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CALGB-70305
  • U10CA037447 (U.S. NIH-bevilling/kontrakt)
  • CDR0000494652 (Registry Identifier: NCI Physician Data Query)
  • NCI-2009-00488 (Registry Identifier: NCI Clinical Trial Reporting Program)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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