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Breast CarcinomaNCT00115505

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

An observational study of Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 227 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Carcinoma
What is being tested?
quality-of-life assessment and Questionnaire Administration
How many people
307 participants
Where
227 sitesUnited States
Study dates
Oct 2005to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with breast cancer with 0-3 positive axillary lymph nodes receiving adjuvant

Who may be able to join

  • Patient must be registered to CALGB 40101
  • Patient must be able to communicate in English

Who cannot join

None listed.

Trial locations and contacts

227 sites in 1 country.

227 sites in 1 country

United States227 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101-0151

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Cleo Craig Cancer Research Clinic

    Lawton, Oklahoma, 73505

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Memorial Medical Center

    Modesto, California, 95355

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Nashville Oncology Associates, PC

    Nashville, Tennessee, 37203

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Mercy Regional Cancer Center at Mercy Medical Center

    Redding, California, 96049

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • Center for Cancer Care at OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Shawnee Mission Medical Center

    Shawnee, Kansas, 66204

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology-Oncology, PC - South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Midwest Hematology Oncology Group, Incorporated

    St Louis, Missouri, 63109

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

  1. 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.

Being tested
quality-of-life assessment, Questionnaire Administration
Keywords
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality-of-life assessmentOther

    Also called 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 AdministrationOther

    Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments

Study groups in NCT00115505
Study groupRoleWhat they receive
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.
Receives: Other: quality-of-life assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree that symptoms interfere with patient functioning according to the National Cancer Institute (NCI) Common Toxicity Criteria

    Measured: Up to 18 months

  2. Relative duration that symptoms interfere with patient functioning according to the NCI Common Toxicity Criteria

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115505
Sponsor's protocol ID
CALGB-70301
Other IDs
CALGB-70301, NCI-2015-00210, U10CA031946, CDR0000433266
Status last verified
Aug 2017
First submitted
22 Jun 2005
Last updated
18 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 227 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree that symptoms interfere with patient functioning according to the National Cancer Institute (NCI) Common Toxicity Criteria (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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