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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03481 | Other Identifier | Registry ID: CTRP (Clinical Trial Reporting Program) | |
| 07100 | Other Identifier | City of Hope Medical Center |
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This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.
PRIMARY OBJECTIVES:
I. To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.
II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.
III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.
OUTLINE:
Patients undergo long term follow-up and complete questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (long term follow-up) | Patients undergo long term follow-up and complete questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-term Follow-up | Other | Undergo long term follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of the study end-points | Will estimation of incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time varying characteristics such as age and body mass index (BMI). Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. Time of entry onto the study in the analysis will be from the date of diagnosis of primary disease. Stepwise logistic regression analysis of endpoints of interest at certain follow-up time may be conducted, accounting for the joint effect of such factors as age, time since diagnosis and treatment, radiation dose, chemotherapy and tumor subtype. | Up to 12 years |
| FACT- Cog | Functional Assessment of Cancer Therapy Cognitive Function | Change from pre-treatment baseline over a 2-year period |
| Cancer induced immune dysfunction | Will analyze patients' tumor, lymph node, and blood samples | Up to 12 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage 0-IIIC breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Mortimer, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Tumor, lymph node, blood
| Questionnaire Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| D017437 |
| Skin and Connective Tissue Diseases |