Quality of Life, Employment, and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2005

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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

This research trial studies quality of life, employment, and informal care cost analysis in
patients with breast cancer receiving chemotherapy. This trial assesses how quality of life
has been affected by cancer, if cancer and its treatment have caused in changes in the
patient's or their spouse's employment and how they have affected the patient and their
extended family, and the impact of peripheral neuropathy caused by chemotherapy on quality
of life. Learning about quality of life and informal care costs may help doctors better
understand how patients feel during treatment, what effects the medicines are having, and in
the future may help both patients and doctors as they decide which medicines to use to treat
cancer.

PRIMARY OBJECTIVES:

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.

Inclusion Criteria:

- Patient must be registered to CALGB 40101

- Patient must be able to communicate in English
We found this trial at
227
sites
2475 Broadway St
Helena, Montana 59601
(406) 442-2480
St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
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417 State St #30
Bangor, Maine 04401
(207) 973-7478
CancerCare of Maine at Eastern Maine Medical Center Our compassionate, experienced physicians specialize in the...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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115 Business loop 70 w
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
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106 Bow Street
Elkton MD, Maryland 21921
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
1304
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
850
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85 Retreat Ave # 2
Hartford, Connecticut 06102
1358
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
429
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1240 S Old Dixie Hwy
Jupiter, Florida 33458
(561) 263-4400
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1271
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
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902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
552
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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100 Campus Dr # 108
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(207) 396-7600
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
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42 E Laurel Rd # 2545
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(800) 826-6737
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1 Medical Center Blvd
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(336) 716-2011
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777 Kimole Ln
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517-265-0900
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422
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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Attleboro, Massachusetts 02703
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632
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4950 Essen Ln
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(225) 767-0847
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
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130 Fisher Road
Berlin, Vermont 05602
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
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605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
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Billings, Montana 59101
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Billings, Montana 59107
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2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
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1101 N 27th St # 201
Billings, Montana 59101
(406) 237-3585
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1441
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44 Binney St
Boston, Massachusetts 02115
(617) 632-6364
Dana-Farber/Brigham and Women's Cancer Center Boston's Brigham and Women's Hospital (BWH) is an international leader...
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960 W. Wooster
Bowling Green, Ohio 43402
419-352-9498
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931 Highland Blvd
Bozeman, Montana 59715
(406) 585-5070
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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400 S Clark St
Butte, Montana 59701
(406) 723-2616
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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Charlottesville, Virginia 22901
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Chicago, Illinois 60625
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
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111 S Grant Avenue
Columbus, Ohio 43215
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Columbus, Ohio 43228
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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793 West State Street
Columbus, Ohio 43222
614-234-5000
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250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Our Concord office...
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
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Dayton, Ohio 45406
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1 Wyoming St
Dayton, Ohio 45409
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Dayton, Ohio 45420
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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9000 North Main Street
Dayton, Ohio 45415
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
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561 W. Central Avenue
Delaware, Ohio 43015
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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1221 Pleasant St
Des Moines, Iowa 50309
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John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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411 Laurel St New Visions
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Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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411 Laurel Street
Des Moines, Iowa 50314
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Duluth, Minnesota 55805
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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502 E 2nd St,
Duluth, Minnesota 55805
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5008 Brittonfield Parkway
East Syracuse, New York 13057
(315) 472-7504
CCOP - Hematology-Oncology Associates of Central New York Hematology/Oncology Associates of CNY (HOACNY) has participated...
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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600 East Blvd
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Exeter, New Hampshire 03833
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
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1107
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
559
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253
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Ft. Smith, AR
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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298 Washington St
Gloucester, Massachusetts 01930
(978) 283-4000
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Goldsboro, North Carolina 27534
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
Altru Cancer Center at Altru Hospital From chemotherapy and radiation therapy to personal holistic services,...
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Grand Rapids, Michigan 49503
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