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Quality of Life, Employment and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer With 0-3 Positive Axillary Lymph Nodes


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Quality of Life, Employment and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer With 0-3 Positive Axillary Lymph Nodes


OBJECTIVES:

Primary

- Compare the degree and duration of symptoms that interfere with functioning in women
with breast cancer with 0-3 positive axillary lymph nodes treated with adjuvant
cyclophosphamide and doxorubicin vs paclitaxel on protocol CALGB-40101.

- Compare the employment consequences of cancer and its treatment on patients treated
with these regimens and on their extended families.

- Determine the prevalence and severity of peripheral neuropathy in patients treated with
these regimens.

Secondary

- Determine the baseline characteristics that are predictive of vulnerability to side
effects that significantly interfere with functioning in patients treated with these
regimens.

- Determine the relative importance of the reasons that patients decided to participate
in protocol CALGB-40101 and how those reasons might change as a consequence of their
experience with treatment.

- Compare the quality-adjusted life years in patients treated with these regimens.

- Determine the type and amount of informal care needs of patients treated with these
regimens.

- Compare the economic consequences of these treatment regimens on employment and
informal care needs in these patients.

- Determine whether specific identifiable clinical adverse events (i.e., neuropathy or
fatigue) are associated with greater economic consequences in patients treated with
these regimens.

- Determine factors predictive of a patient being employed during and after cancer
treatment.

- Compare the prevalence and severity of peripheral neuropathy in patients treated with
these regimens.

- Determine the relationship between the severity of peripheral neuropathy after
treatment and patients' functioning, including physical, psychological, and social
functioning.

- Determine the neurotoxicity items in the Symptoms in Relation to Patient Functioning
Survey ©-1271) used in this protocol by correlating its results with the
FACT-Neurotoxicity Subscale ©-669) and the EORTC QLQ-C30 and Breast Cancer module ©-259
and C-618).

OUTLINE: This is a multicenter, companion study.

Patients complete quality of life, employment, and informal care cost questionnaires, and
peripheral neuropathy assessments at baseline (before beginning treatment on protocol
CALGB-40101), in weeks 5-6 and 9-10, and in months 9 and 18.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary
lymph nodes

- Registered on protocol CALGB-40101

- Hormone receptor status:

- Any estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex:

- Female

Menopausal status:

- Premenopausal or postmenopausal

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic:

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other:

- Able to communicate in English

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Craig A. Bunnell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000433266

NCT ID:

NCT00115505

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage II breast cancer
  • stage IB breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-negative breast cancer
  • progesterone receptor-positive breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Rita's Medical CenterLima, Ohio  45801
Memorial Hospital of South BendSouth Bend, Indiana  46601
Cape Cod HospitalHyannis, Massachusetts  02601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Sibley Memorial HospitalWashington, District of Columbia  20016
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Mount Carmel Health - West HospitalColumbus, Ohio  43222
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Swedish Covenant HospitalChicago, Illinois  60625
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Sturdy Memorial HospitalAttleboro, Massachusetts  02703
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Mecosta County Medical CenterBig Rapids, Michigan  49307
Community Cancer Center of MonroeMonroe, Michigan  48162
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Mountainview MedicalBerlin, Vermont  05602
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
California Cancer Center - Woodward Park OfficeFresno, California  93720
Northeast Georgia Medical CenterGainesville, Georgia  30501
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
McFarland Clinic, PCAmes, Iowa  50010
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Foote Memorial HospitalJackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
North Coast Cancer Care - ClydeClyde, Ohio  43410
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Grant Medical Center Cancer CareColumbus, Ohio  43215
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Clinton Memorial HospitalWilmington, Ohio  45177
Cleo Craig Cancer Research ClinicLawton, Oklahoma  73505
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Cancer Resource Center at King's Daughters Medical CenterAshland, Kentucky  41101
Lowell General HospitalLowell, Massachusetts  01854
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Pardee Memorial HospitalHendersonville, North Carolina  28791
Martha Jefferson Hospital Cancer Care CenterCharlottesville, Virginia  22901
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
Miriam HospitalProvidence, Rhode Island  02906
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Lakes Region General HospitalLaconia, New Hampshire  03246
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Center for Cancer Care at OSF Saint Anthony Medical CenterRockford, Illinois  61108
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Parvin Radiation OncologyKansas City, Missouri  64116
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Memorial Medical CenterModesto, California  95355
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
Center for Cancer Care at Exeter HospitalExeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Faxton Regional Cancer CenterUtica, New York  13502
Mercy Regional Cancer Center at Mercy Medical CenterRedding, California  96049
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Addison Gilbert HospitalGloucester, Massachusetts  01930
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Nashville Oncology Associates, PCNashville, Tennessee  37203
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211