Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00068328

First received: September 10, 2003

Last updated: February 18, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2003

Last Updated Date

February 18, 2011

Start Date ^ICMJE

August 2003

Estimated Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00068328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

Official Title ^ICMJE

Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer

Brief Summary

RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life.

PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.

Detailed Description

OBJECTIVES:

Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable, newly diagnosed breast cancer.
Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients.
Determine the relationships between preference-based chemotherapy decisions, quality of life, and satisfaction with treatment decisions in these patients.
Determine the disease-free survival and competing causes of mortality of these patients.
Determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see.
Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model.
Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment.
Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment.

OUTLINE: This is a cohort study.

Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years.

Patients are followed annually for at least 5 years.

PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study within 18-24 months.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Breast Cancer
Psychosocial Effects of Cancer and Its Treatment

Intervention ^ICMJE

Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Arm (s)

Not Provided

Publications *

Mandelblatt JS, Sheppard VB, Hurria A, Kimmick G, Isaacs C, Taylor KL, Kornblith AB, Noone AM, Luta G, Tallarico M, Barry WT, Hunegs L, Zon R, Naughton M, Winer E, Hudis C, Edge SB, Cohen HJ, Muss H; Cancer Leukemia Group B. Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. J Clin Oncol. 2010 Jul 1;28(19):3146-53. Epub 2010 Jun 1.
Mandelblatt J, Sheppard V, Hurria A, et al.: Patient preference as a determinant of breast cancer adjuvant chemotherapy use in older women: CALGB #369901. [Abstract] J Clin Oncol 27 (Suppl 15): A-9544, 2009.
Kreling B, Figueiredo MI, Sheppard VL, Mandelblatt JS. A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology. 2006 Apr 6; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1360

Completion Date

Not Provided

Estimated Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed primary adenocarcinoma of the breast
- Operable disease
- Invasive and unilateral tumor
- No more than 20 weeks since diagnosis
- T1-4 (tumor size ≥ 1 cm), N0, M0 OR
- T1-4, N1-3, M0
No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
Hormone receptor status:
- Any estrogen receptor status

PATIENT CHARACTERISTICS:

Age

65 and over

Sex

Female

Menopausal status

Not specified

Performance status

Any performance status

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No other malignancy except those for which the patient has completed treatment AND is considered to be at less than 30% risk of recurrence
History of non-melanoma skin cancer allowed
Sufficient cognitive function to consent to and complete interviews
English or Spanish speaking

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Gender

Female

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00068328

Other Study ID Numbers ^ICMJE

CDR0000321396, CALGB-369901

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Jeanne Mandelblatt, MD, MPH	Lombardi Cancer Research Center
Investigator:	Alice B. Kornblith, PhD	Dana-Farber Cancer Institute
Investigator:	Hyman B. Muss, MD	University of Vermont
Investigator:	Stephen B. Edge, MD	Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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