Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
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| ClinicalTrials.gov Identifier: NCT00582478 |
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Recruitment Status
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Active, not recruiting
First Posted
: December 28, 2007
Last Update Posted
: October 4, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Behavioral: questionnaires |
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 : | Observational |
| Estimated Enrollment : | 650 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients |
| Study Start Date : | October 2001 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
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1
women with breast cancer
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Behavioral: questionnaires
Participants will be followed regularly at 3, 6, 12, and 18-month intervals
Other Names:
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- The study measurements are quality of life questionnaires [ Time Frame: 7 years 2 months ]
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 |
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
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): NCT00582478
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Kimberly Van Zee, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00582478 History of Changes |
| Other Study ID Numbers: |
01-120 |
| First Posted: | December 28, 2007 Key Record Dates |
| Last Update Posted: | October 4, 2017 |
| Last Verified: | October 2017 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Breast cancer Quality of Life |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |