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Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Wake Forest University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582478
First received: December 21, 2007
Last updated: November 2, 2015
Last verified: November 2015
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]
Estimated Enrollment: 650
Study Start Date: October 2001
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Other Names:
  • Functional Assessment of Cancer Therapy - Fact B, 2. Beck Depression Inventory, 3. MOS Sexual Functioning
  • Questionnaire, 4. Body Appearance Scale, 5. SF-36 Health Status Questionnaire, 6.
  • Global Quality of Life, 7. Interval Medical and Reproductive History, 8. Physical
  • Symptoms Checklist, 9. RAND Social Support Scale, 10. Funtional Assessment of
  • Chronic Illness Therapy-Spiritual Well Being (FACIT-Sp) 11.Optimisim, 12 Brief COPE
  • Scale, 13. Illness Intrusive Scale, 14. Posttraumatic Growth Inventory (PTGI), 15.
  • Quality of Life in Adult Cancer Survivors (QLACS).

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   (Adult, Senior)
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
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: 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

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

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582478     History of Changes
Other Study ID Numbers: 01-120 
Study First Received: December 21, 2007
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 26, 2016