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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 gennaio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

568

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: quality of life assessment
Ancillary studies
Altro: educational intervention
Receive lymphedema educational materials
Altri nomi:
  • intervento, educativo
Sperimentale: 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.
Altro: quality of life assessment
Ancillary studies
Altro: educational intervention
Receive lymphedema educational materials
Altri nomi:
  • intervento, educativo
Procedura: Physical therapy
Complete physical therapy-focused intervention
Altri nomi:
  • fisioterapia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2006

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

15 giugno 2017

Date di iscrizione allo studio

Primo inviato

13 settembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2006

Primo Inserito (Stima)

15 settembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 gennaio 2019

Ultimo verificato

1 gennaio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CALGB-70305
  • U10CA037447 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000494652 (Identificatore di registro: NCI Physician Data Query)
  • NCI-2009-00488 (Identificatore di registro: NCI Clinical Trial Reporting Program)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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