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

PRIMARY OBJECTIVES:

I. To compare the individual treatment arms relative to the degree that symptoms interfere
with patient functioning and to characterize and compare the relative duration that symptoms
interfere with patient functioning.

II. To assess the employment consequences of cancer and its treatment on the patient and
extended family, and to compare treatment arms relative to these consequences.

III. To determine the prevalence and severity of peripheral neuropathy in breast cancer
patients treated by adjuvant chemotherapy with dose dense (every two weeks) paclitaxel for 4
cycles, from study entry to 5 years after the start of treatment.

SECONDARY OBJECTIVES:

I. To identify baseline characteristics that are predictive for patients being more
vulnerable to experiencing side effects which significantly interfere with patient
functioning.

II. To identify and characterize the relative importance of the reasons that patients decide
to participate in the treatment study (Cancer and Leukemia Group B [CALGB] 40101) and how
those reasons might change as a consequence of their experience with treatment.

III. To compare the quality-adjusted life years between adjuvant chemotherapy (AC) and
paclitaxel or between short and long schedules, regardless of the other factor.

IV. To measure, over the course of adjuvant therapy, the type and amount of informal care
needs of the patient.

V. Using a societal perspective, estimate and compare the economic consequences on
employment and informal care needs.

VI. To determine if specific identifiable clinical adverse events (i.e., neuropathy or
fatigue) are associated with greater economic consequences.

VII. To examine factors which are predictive of a patient being employed during and after
cancer treatment.

VIII. To compare the prevalence and severity of peripheral neuropathy in breast cancer
patients treated by dose dense paclitaxel to those patients treated with dose dense CA
(cyclophosphamide and doxorubicin).

IX. To conduct an exploratory examination of the relationship between the severity of
peripheral neuropathy after paclitaxel treatment (4 and 6 cycles) and breast cancer
patients' functioning, including physical, psychological, and social functioning.

X. To validate the neurotoxicity items in the Symptoms in Relation to Patient Functioning
Survey (C-1271) used in this protocol by correlating its results with the Functional
Assessment of Cancer Therapy (FACT)-Neurotoxicity Subscale (C-669) and the European
Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire
(QLQ)-Core (C)30 and Breast Cancer module (C-259 and C-618).

OUTLINE:

Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire,
Medical Outcome Study (MOS) Social Support Survey, Patient Preferences, CALGB Background
Information, and European Quality of Life 5-Dimensions (EQ-5D) and QOL Assessment Form;
Employment and Informal Care Cost Assessments; and Peripheral Neuropathy of the FACT-NTX
subscale at baseline, 29-42 and 57-70 days, and at 9 and 18 months. Patients meeting the
cut-off score for peripheral neuropathy on the FACT-NTX subscale at 18 months complete the
Symptoms in Relation to Patient Functioning Survey, FACT-NTX subscale, the EORTC QLQ-C30,
EORTC QLQ-BR23, and the Medications Used for Treating Peripheral Neuropathy at 24, 36, 48,
and 60 months.

Inclusion Criteria:

- Patient must be registered to CALGB 40101

- Patient must be able to communicate in English