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Elevate! : An Elderly Breast Cancer Cohort Study

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ClinicalTrials.gov Identifier: NCT03818087
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date December 19, 2018
First Posted Date January 28, 2019
Last Update Posted Date March 13, 2019
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
 (submitted: January 23, 2019)
  • Adjuvant treatment recommendations [ Time Frame: 7 years ]
    Report treatment recommendations made to patients enrolled on the cohort
  • Adherence to hormonal therapy [ Time Frame: 7 years ]
    We will survey patients on adherence
  • Barriers to treatment and adherence [ Time Frame: 7 years ]
    We will survey patients on the reasons for adherence and poor adherence
  • Treatment patterns by age and other characteristics [ Time Frame: 7 years ]
    We will examine treatment receipt and patterns by subtype of disease
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03818087 on ClinicalTrials.gov Archive Site
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
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.
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.
Study Groups/Cohorts Elevate
Participants over the age of 70 years old with early-stage breast cancer will be recruited.
Intervention: Behavioral: Observational cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2019)
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:

  • Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)
  • No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older
  • Any gender is eligible
  • Invasive, non-metastatic breast cancer at diagnosis
  • Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible)
  • Any breast cancer subtype is allowed
  • Breast cancer-diagnosing biopsy within 90 days of enrollment
  • Receiving or will receive medical oncology care (+/- surgical and radiation oncology treatments) at the participating center: DFCI/satellites and affiliate sites
  • Patients must be able to understand, speak, and read English or assign a designated caregiver/proxy for the duration of the study who understands, speaks, and reads English and who is willing to assist with filling out the survey components which do not have a validated, translated version. This is because the surveys are not readily available in multiple languages as a whole, although some components (such as the Geriatric Assessment and PROs are readily available in multiple languages).
  • If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test done at baseline (Appendix E), a proxy/designee must then be assigned to help the patient fill out the questionnaires for the duration of the study in order to participate. The treating provider will also be notified about the cognitive impairment.
  • Ability to provide informed consent

Exclusion Criteria:

  • Pathological or clinical stage 0, IV disease
  • Those with nodal or metastatic recurrences at the time of enrollment
  • Unable to speak and read English AND no designee who speaks and reads English, as above
  • Unable to provide informed consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rachel A. Freedman, MD, MPH 617-632-3800 rafreedman@partners.org
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].
Responsible Party Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Rachel A Freedman, MD, MPH Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date March 2019