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

18 Years
Open (Enrolling)
Breast Cancer

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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



- 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

- 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

- 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

- 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

- 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.

Inclusion Criteria


- Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary
lymph nodes

- Registered on protocol CALGB-40101

- Hormone receptor status:

- Any estrogen and/or progesterone receptor status



- 18 and over


- Female

Menopausal status:

- Premenopausal or postmenopausal

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- Able to communicate in English


Biologic therapy

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:


Principal Investigator

Craig A. Bunnell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage II breast cancer
  • stage IB breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-negative breast cancer
  • progesterone receptor-positive breast cancer
  • Breast Neoplasms



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