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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115505
First Posted: June 23, 2005
Last Update Posted: August 18, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose
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 Intervention
Breast Carcinoma Other: quality-of-life assessment Other: Questionnaire Administration

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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

Enrollment: 307
Study Start Date: October 2005
Study Completion Date: June 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

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 Submitted: June 22, 2005
First Posted: June 23, 2005
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