Condition or disease | Intervention/treatment |
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Breast Cancer | Behavioral: Observational cohort |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study |
Actual Study Start Date : | February 19, 2019 |
Estimated Primary Completion Date : | November 1, 2025 |
Estimated Study Completion Date : | November 1, 2028 |
Group/Cohort | Intervention/treatment |
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Elevate
Participants over the age of 70 years old with early-stage breast cancer will be recruited.
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Behavioral: Observational cohort
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rachel A. Freedman, MD, MPH | 617-632-3800 | rafreedman@partners.org |
United States, Maine | |
Northern Light Cancer Care | Recruiting |
Bangor, Maine, United States, 04401 | |
Contact: Sarah Sinclair, DO | |
United States, Massachusetts | |
Brigham and Women Hospital | Active, not recruiting |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Rachel A Freedman, MD, MPH 617-632-3800 rafreedman@partners.org | |
Principal Investigator: Rachel A Freedman, MD, MPH | |
United States, Rhode Island | |
Lifespan Cancer Institute | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Mary Anne Fenton, MD |
Principal Investigator: | Rachel A Freedman, MD, MPH | Dana-Farber Cancer Institute |
Tracking Information | |||||||||||||
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First Submitted Date | December 19, 2018 | ||||||||||||
First Posted Date | January 28, 2019 | ||||||||||||
Last Update Posted Date | May 21, 2021 | ||||||||||||
Actual Study Start Date | February 19, 2019 | ||||||||||||
Estimated Primary Completion Date | November 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | Elevate! : An Elderly Breast Cancer Cohort Study | ||||||||||||
Official Title | Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study | ||||||||||||
Brief Summary | This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer. | ||||||||||||
Detailed Description | 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. | ||||||||||||
Study Type | Observational | ||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Retention: Samples With DNA Description:
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.
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Sampling Method | Non-Probability Sample | ||||||||||||
Study Population | Age 70 or older at the time of diagnosis | ||||||||||||
Condition | Breast Cancer | ||||||||||||
Intervention | Behavioral: Observational cohort
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
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Study Groups/Cohorts | Elevate
Participants over the age of 70 years old with early-stage breast cancer will be recruited.
Intervention: Behavioral: Observational cohort
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status | Recruiting | ||||||||||||
Estimated Enrollment |
200 | ||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||
Estimated Study Completion Date | November 1, 2028 | ||||||||||||
Estimated Primary Completion Date | November 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 70 Years and older (Older Adult) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts |
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Listed Location Countries | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT03818087 | ||||||||||||
Other Study ID Numbers | 18-634 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute | ||||||||||||
Study Sponsor | Dana-Farber Cancer Institute | ||||||||||||
Collaborators | Susan G. Komen Breast Cancer Foundation | ||||||||||||
Investigators |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||
Verification Date | May 2021 |