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

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00115505

Purpose

RATIONALE: Studying quality-of-life, employment, peripheral neuropathy, and informal care costs in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with breast cancer.

PURPOSE: This clinical trial is studying quality of life, employment, peripheral neuropathy, and informal care costs in women who are receiving chemotherapy for breast cancer.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Procedure: quality-of-life assessment

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	280
Study Start Date:	October 2005
Estimated Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115505

Show 255 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:	Craig A. Bunnell, MD	Dana-Farber Cancer Institute
Investigator:	Bruce E. Hillner, MD	Massey Cancer Center
Investigator:	Jeanne Mandelblatt, MD, MPH	Lombardi Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000433266, CALGB-70301
Study First Received:	June 22, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00115505
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

quality of life
stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009