Quality of Life, Employment, and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer
Recruitment status was Active, not recruiting
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.
|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|
|Study Start Date:||October 2005|
|Estimated Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115505
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|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|