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


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

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

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Studying quality-of-life, employment, 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, and informal care costs in women who are receiving chemotherapy for breast cancer.

Condition Intervention
Quality of Life
stage I breast cancer
stage II breast cancer
 Procedure: quality-of-life assessment
 Procedure: supportive care/therapy

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Companion Study of Quality of Life, Employment, and Informal Care Costs in Women Receiving Adjuvant Chemotherapy for High-Risk Node-Negative Breast Cancer

Further Study Details: 

OBJECTIVES: Primary

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.

OUTLINE: This is a multicenter, companion study.

Patients complete quality of life, employment, and informal care cost questionnaires at baseline (before beginning treatment on protocol ), 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 above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00115505


Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000433266; CALGB-70301
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 22, 2005
ClinicalTrials.gov Identifier:  NCT00115505
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05


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