Status:
ACTIVE_NOT_RECRUITING
Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
Lead Sponsor:
Thomas Jefferson University
Conditions:
Stage 0 Breast Cancer AJCC v6 and v7
Stage I Breast Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This phase II trial studies how well telehealth works in improving adherence to endocrine (anti-estrogen) therapy in participants with estrogen receptor and/or progesterone receptor positive (hormone ...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate if the utilization of automated patient reported outcomes and follow up Telehealth can improve patient adherence with adjuvant endocrine therapy during the first 12...
Eligibility Criteria
Inclusion
- • Signed informed consent obtained prior to any study specific assessments and procedures
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Women or men diagnosed with stage 0-III hormone receptor positive (estrogen receptor positive \[ER\] and /or progesterone receptor \[PR\] positive) breast cancer
- \* Staging for eligibility should utilize the most recent American Joint Committee on Cancer (AJCC) breast cancer staging version
- Patients (Pts) must have undergone breast surgery for their diagnosis of breast cancer
- Adjuvant endocrine therapy has been prescribed by their treating physician
- \* Patients may receive concurrent adjuvant radiation therapy plus endocrine therapy in the post-operative setting
- Have a cell phone with text messaging ability
- Have access to a computer, tablet, or smart phone to complete electronic surveys
- Patient must be willing to setup an online Jefferson MyChart account
- Patients who have been on endocrine therapy for more than 4 years
Exclusion
- Pts with stage IV metastatic breast cancer
- Patients unable to participate in patient portal communication (e.g. do not have either a smart phone, laptop, access to a computer and/ or access to a device with a webcam)
- Pts who are non-English speaking and English illiterate
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT04054557
Start Date
July 31 2019
End Date
December 31 2025
Last Update
August 21 2025
Active Locations (5)
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1
Jefferson Health - South Jersey
Washington Township, New Jersey, United States, 08080
2
Thomas Jefefrson University
Philadelphia, Pennsylvania, United States, 19107
3
Methodist Hospital
Philadelphia, Pennsylvania, United States, 19148
4
Jefferson Health - Northeast
Torresdale, Pennsylvania, United States, 19114