Quality of Life, Employment, and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer
NCT ID: NCT00115505
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
307 participants
OBSERVATIONAL
2005-10-31
2016-06-30
Brief Summary
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Detailed Description
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I. To compare the individual treatment arms relative to the degree that symptoms interfere with patient functioning and to characterize and compare the relative duration that symptoms interfere with patient functioning.
II. To assess the employment consequences of cancer and its treatment on the patient and extended family, and to compare treatment arms relative to these consequences.
III. To determine the prevalence and severity of peripheral neuropathy in breast cancer patients treated by adjuvant chemotherapy with dose dense (every two weeks) paclitaxel for 4 cycles, from study entry to 5 years after the start of treatment.
SECONDARY OBJECTIVES:
I. To identify baseline characteristics that are predictive for patients being more vulnerable to experiencing side effects which significantly interfere with patient functioning.
II. To identify and characterize the relative importance of the reasons that patients decide to participate in the treatment study (Cancer and Leukemia Group B \[CALGB\] 40101) and how those reasons might change as a consequence of their experience with treatment.
III. To compare the quality-adjusted life years between adjuvant chemotherapy (AC) and paclitaxel or between short and long schedules, regardless of the other factor.
IV. To measure, over the course of adjuvant therapy, the type and amount of informal care needs of the patient.
V. Using a societal perspective, estimate and compare the economic consequences on employment and informal care needs.
VI. To determine if specific identifiable clinical adverse events (i.e., neuropathy or fatigue) are associated with greater economic consequences.
VII. To examine factors which are predictive of a patient being employed during and after cancer treatment.
VIII. To compare the prevalence and severity of peripheral neuropathy in breast cancer patients treated by dose dense paclitaxel to those patients treated with dose dense CA (cyclophosphamide and doxorubicin).
IX. To conduct an exploratory examination of the relationship between the severity of peripheral neuropathy after paclitaxel treatment (4 and 6 cycles) and breast cancer patients' functioning, including physical, psychological, and social functioning.
X. To validate the neurotoxicity items in the Symptoms in Relation to Patient Functioning Survey (C-1271) used in this protocol by correlating its results with the Functional Assessment of Cancer Therapy (FACT)-Neurotoxicity Subscale (C-669) and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 and Breast Cancer module (C-259 and C-618).
OUTLINE:
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire, Medical Outcome Study (MOS) Social Support Survey, Patient Preferences, CALGB Background Information, and European Quality of Life 5-Dimensions (EQ-5D) and QOL Assessment Form; Employment and Informal Care Cost Assessments; and Peripheral Neuropathy of the FACT-NTX subscale at baseline, 29-42 and 57-70 days, and at 9 and 18 months. Patients meeting the cut-off score for peripheral neuropathy on the FACT-NTX subscale at 18 months complete the Symptoms in Relation to Patient Functioning Survey, FACT-NTX subscale, the EORTC QLQ-C30, EORTC QLQ-BR23, and the Medications Used for Treating Peripheral Neuropathy at 24, 36, 48, and 60 months.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (QOL, employment, informal care cost)
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form; Employment and Informal Care Cost Assessments; and Peripheral Neuropathy of the FACT-NTX subscale at baseline, 29-42 and 57-70 days, and at 9 and 18 months. Patients meeting the cut-off score for peripheral neuropathy on the FACT-NTX subscale at 18 months complete the Symptoms in Relation to Patient Functioning Survey, FACT-NTX subscale, the EORTC QLQ-C30, EORTC QLQ-BR23, and the Medications Used for Treating Peripheral Neuropathy at 24, 36, 48, and 60 months.
quality-of-life assessment
Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
Questionnaire Administration
Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments
Interventions
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quality-of-life assessment
Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
Questionnaire Administration
Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must be able to communicate in English
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Craig A. Bunnell, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
California Cancer Center - Woodward Park Office
Fresno, California, United States
Memorial Medical Center
Modesto, California, United States
Mercy Regional Cancer Center at Mercy Medical Center
Redding, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Swedish Covenant Hospital
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States
Mercy Capitol Hospital
Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Menorah Medical Center
Overland Park, Kansas, United States
Shawnee Mission Medical Center
Shawnee, Kansas, United States
Cancer Resource Center at King's Daughters Medical Center
Ashland, Kentucky, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Parvin Radiation Oncology
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, United States
Faxton Regional Cancer Center
Utica, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Wood County Oncology Center
Bowling Green, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
North Coast Cancer Care - Clyde
Clyde, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Fisher-Titus Medical Center
Norwalk, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Cleo Craig Cancer Research Clinic
Lawton, Oklahoma, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Nashville Oncology Associates, PC
Nashville, Tennessee, United States
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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CALGB-70301
Identifier Type: -
Identifier Source: secondary_id
NCI-2015-00210
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000433266
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-70301
Identifier Type: -
Identifier Source: org_study_id
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