Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
women with breast cancer
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Participants will be followed regularly at 3, 6, 12, and 18-month intervals
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The study measurements are quality of life questionnaires
Time Frame: 7 years 2 months
|
7 years 2 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tracy-Ann Moo, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Status
- Demography
- Epidemiologic Measurements
- Epidemiologic Factors
- Medical History Taking
- Weights and Measures
- Surveys and Questionnaires
- Quality of Life
- Reproductive History
- prostacyclin synthetase
Other Study ID Numbers
- 01-120
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