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Trial record 8 of 68732 for:    cancer

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

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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Observational cohort

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Elevate
Participants over the age of 70 years old with early-stage breast cancer will be recruited.
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.




Primary Outcome Measures :
  1. Adjuvant treatment recommendations [ Time Frame: 7 years ]
    Report treatment recommendations made to patients enrolled on the cohort

  2. Adherence to hormonal therapy [ Time Frame: 7 years ]
    We will survey patients on adherence

  3. Barriers to treatment and adherence [ Time Frame: 7 years ]
    We will survey patients on the reasons for adherence and poor adherence

  4. Treatment patterns by age and other characteristics [ Time Frame: 7 years ]
    We will examine treatment receipt and patterns by subtype of disease


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Age 70 or older at the time of diagnosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818087


Contacts
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Contact: Rachel A. Freedman, MD, MPH 617-632-3800 rafreedman@partners.org

Locations
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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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Susan G. Komen Breast Cancer Foundation
Investigators
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Principal Investigator: Rachel A Freedman, MD, MPH Dana-Farber Cancer Institute

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Responsible Party: Rachel Freedman, MD, MPH, Primary Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03818087     History of Changes
Other Study ID Numbers: 18-634
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (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
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].

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases