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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00115505
First received: June 22, 2005
Last updated: September 28, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 280
Study Start Date: October 2005
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115505

  Show 227 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
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 July 20, 2014