We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00115505
Recruitment Status : Completed
First Posted : June 23, 2005
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This research trial studies quality of life, employment, and informal care cost analysis in patients with breast cancer receiving chemotherapy. This trial assesses how quality of life has been affected by cancer, if cancer and its treatment have caused in changes in the patient's or their spouse's employment and how they have affected the patient and their extended family, and the impact of peripheral neuropathy caused by chemotherapy on quality of life. Learning about quality of life and informal care costs may help doctors better understand how patients feel during treatment, what effects the medicines are having, and in the future may help both patients and doctors as they decide which medicines to use to treat cancer.

Condition or disease Intervention/treatment
Breast Carcinoma Other: quality-of-life assessment Other: Questionnaire Administration

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : October 2005
Primary Completion Date : July 2015
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Ancillary-Correlative (QOL, employment, informal care cost)
Patients complete the QOL Assessments comprising the Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and 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.
Other: quality-of-life assessment
Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments


Outcome Measures

Primary Outcome Measures :
  1. Degree that symptoms interfere with patient functioning according to the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: Up to 18 months ]
  2. Relative duration that symptoms interfere with patient functioning according to the NCI Common Toxicity Criteria [ Time Frame: Up to 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breast cancer with 0-3 positive axillary lymph nodes receiving adjuvant
Criteria

Inclusion Criteria:

  • Patient must be registered to CALGB 40101
  • Patient must be able to communicate in English
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115505


  Show 227 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Craig A. Bunnell, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00115505     History of Changes
Other Study ID Numbers: CALGB-70301
NCI-2015-00210 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000433266 ( Registry Identifier: NCI Physician Data Query )
First Posted: June 23, 2005    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Progesterone
Estrogens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs