Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERLong-term Follow-up
Undergo long term follow-up
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
City of Hope Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of breast cancer, stage 0-IIIC * Partial or entire treatment at City of Hope * Must be registered before adjuvant therapy and ideally before definitive local therapy
Exclusion criteria
* Stage IV breast cancer * Recurrent breast cancer * Prior cancers, chemotherapy or radiation \* (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates of the study end-points | Up to 12 years | 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. |
| FACT- Cog | Change from pre-treatment baseline over a 2-year period | Functional Assessment of Cancer Therapy Cognitive Function |
| Cancer induced immune dysfunction | Up to 12 years | Will analyze patients' tumor, lymph node, and blood samples |
Countries
United States
Outcome results
None listed