Quality of Life, Employment, and Informal Care Costs in Women Who Are Receiving Chemotherapy for Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: quality-of-life assessment |
| Study Type: | Observational |
| 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 |
| Estimated Enrollment: | 280 |
| Study Start Date: | October 2005 |
| Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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
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
Contacts and Locations
Show 227 Study Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00115505 History of Changes |
| Other Study ID Numbers: | CDR0000433266, CALGB-70301 |
| Study First Received: | June 22, 2005 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 13, 2013