Clinical trial · Observational
Elevate! : An Elderly Breast Cancer Cohort Study
Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
NCT03818087CI-TRIAL-00099347active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational cohort | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Elevate
- description
- Participants over the age of 70 years old with early-stage breast cancer will be recruited.
- interventionNames
- Behavioral: Observational cohort
Primary outcomes (4)
- measure
- Adjuvant treatment recommendations
- timeFrame
- 7 years
- description
- Report treatment recommendations made to patients enrolled on the cohort
- measure
- Adherence to hormonal therapy
- timeFrame
- 7 years
- description
- We will survey patients on adherence
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.