ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
University of Texas Southwestern Medical Center
Wake Forest University
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582478
  Purpose

The purpose of this study is to look at how breast cancer treatment affects quality of life in women of different ages. The U.S. Army Breast Cancer Research Program funds this study. In this research project, we wish to study a woman's quality of life after breast cancer treatment as related to her health. We want to know how you feel about your quality of life.


Condition Intervention
Breast Cancer
Behavioral: questionnaires

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The study measurements are quality of life questionnaires [ Time Frame: 7 years 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   650
Study Start Date:   October 2001
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
women with breast cancer
Behavioral: questionnaires
Participants will be followed regularly at 3, 6, 12, and 18-month intervals

Detailed Description:

This multi-center study will include self-referred. This project is a prospective cohort study of 800 women aged 18 and over who are newly diagnosed with breast cancer. Women will be recruited into the study within 6 months after diagnosis and followed for 18 months. The primary purpose of the proposed study is to examine mechanisms that may explain age differences in the health-related quality of life of women who have been diagnosed with a first-time breast cancer. The studies will examine psychosocial factors such as social support, coping strategies, resiliency, and the impact of cancer on life responsibilities as explanations of age-associated factors affecting HRQL. This project is an observational, longitudinal study of women aged 18 and over who are newly diagnosed with breast cancer. In order to examine both the short- and longer-term impact of breast cancer on HRQL, the study will survey women post diagnosis and follow them at 3, 6, 12, and 18 months. A secondary purpose is to have this large cohort of breast cancer patients serve as a comparison group for other studies in the Behavioral Center of Excellence award given to Wake Forest Medical Center by the Department of Defense. Extensive baseline data will be collected by an in-depth chart review and interview for additional data. Information will be gathered on demographics, clinical and treatment variables. The study intervention consists of collecting data on health-related quality of life through specific questionnaires.

Data collection instruments will be mailed to participants at regularly scheduled intervals accompanied by a stamped,addressed envelope. If the participant does not return study forms within three weeks, the participant will be called.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

First time breast cancer patients


Criteria

Inclusion Criteria:

  • Female
  • Aged 18 or older at the time of breast cancer diagnosis
  • English-speaking
  • Community dwelling (i.e. not living in a residential care or correctional facility)
  • Diagnosed with invasive breast cancer Stage I, II, or III within the previous 6 months
  • First time diagnosis
  • Have physician agreement for participation
  • Provide informed consent

Exclusion Criteria:

  • Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
  • Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
  • Stage IV breast malignancy
  • Residency outside of the United States
  • For women ages 45 years and younger only: Those participants < 45 years who were having regular menstrual cycles at the time of diagnosis will be excluded from this protocol. This study will only be enrolling women in this age category who have had a prior hysterectomy or were having irregular menstrual cycles at the time of diagnosis. Women with regular menstrual cycles will be enrolled into a companion project (i.e., Menstrual Cycle Maintenance
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582478

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10065

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Texas Southwestern Medical Center
Wake Forest University

Investigators
Principal Investigator:     Kimberly Van Zee, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Kimberly Van Zee, MD )
Study ID Numbers:   01-120
First Received:   December 21, 2007
Last Updated:   March 18, 2008
ClinicalTrials.gov Identifier:   NCT00582478
Health Authority:   United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast cancer  
Quality of Life  

Study placed in the following topic categories:
Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 31, 2008




Links to all studies - primarily for crawlers