Trial Information

Quality of Life, Employment and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer With 0-3 Positive Axillary Lymph Nodes

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.