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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
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This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. Researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevate | Participants over the age of 70 years old with early-stage breast cancer will be recruited. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational cohort | Behavioral | Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant treatment recommendations | Report treatment recommendations made to patients enrolled on the cohort | 7 years |
| Adherence to hormonal therapy | We will survey patients on adherence | 7 years |
| Barriers to treatment and adherence | We will survey patients on the reasons for adherence and poor adherence | 7 years |
| Treatment patterns by age and other characteristics | We will examine treatment receipt and patterns by subtype of disease | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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Age 70 or older at the time of diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Rachel A Freedman, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Light Cancer Care | Bangor | Maine | 04401 | United States | ||
| Brigham and Women Hospital |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication.
Requests may be directed to: [contact information for Sponsor- Investigator or designee].
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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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Archival tissue will be collected from participant's prior surgeries and procedures. Some participants undergoing breast surgery during the five years of participation may have a sample of fresh tissue taken for research purposes in the operating room. Blood will be collected at registration and at serial timepoints over a period of five years.
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Lifespan Cancer Institute | Providence | Rhode Island | 02903 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |