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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.
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
OBJECTIVES: Primary
- Compare the degree and duration of symptoms that interfere with functioning in women with high-risk node-negative breast cancer treated with adjuvant cyclophosphamide and doxorubicin vs paclitaxel on protocol .
- Compare the employment consequences of cancer and its treatment on patients treated with these regimens and on their extended families.
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
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive carcinoma of the breast
- Node-negative disease
- High-risk disease
- Registered on protocol
- 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
Location and Contact Information
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
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
Resources
- Lean for Life: The truth about weight loss program. (Chase Freedom)

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