Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
NCT ID: NCT04054557
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
305 participants
INTERVENTIONAL
2019-07-31
2025-12-31
Brief Summary
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Detailed Description
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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 months of study participation.
II. To evaluate if the utilization of Smart Pill Bottles and follow-up Telehealth encounters can improve patient adherence with adjuvant endocrine therapy during the first 12 months of study participation.
SECONDARY OBJECTIVES:
I. To evaluate if the utilization of automated patient reported outcome and follow-up Telehealth encounters can improve quality of life and decrease side effects while taking adjuvant endocrine therapy.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Patients receive standard of care office visits approximately every 3 months for one year.
ARM II: Patients receive standard of care as in Arm I and 4 automated electronic surveys every 3 weeks (+/- 1 weeks) for a total of 18 electronic surveys over one year. Patients who report severe or very severe side effects, or stopping or are thinking about stopping their endocrine therapy (ET) will have a follow up encounter with a research coordinator.
ARM III: Patients receive a wireless smart pill bottle that performs daily time-specific reminders to open the pill bottle and take the medication. Additional messages are triggered by the pill bottle when non-adherence is indicated (lack of bottle opening or no change in remaining pills), as well as when medication is skipped.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (Standard of Care office Visits)
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Best Practice
Receive 4 in-office visits with oncologist
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Arm II (Standard of Care Office Visits, survey, telehealth)
Patients receive standard of care as in Arm I and 4 automated electronic surveys every 3 weeks (+/- 1 weeks) for a total of 18 electronic surveys over one year. Patients who report severe or very severe side effects, or stopping or are thinking about stopping their ET will have a follow up encounter with a research coordinator.
Telemedicine
Participate in virtual visits with oncologist
Best Practice
Receive 4 in-office visits with oncologist
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete electronic survey
Arm III (Smart Pill Bottle, messaging)
Patients receive a wireless smart pill bottle that performs daily time-specific reminders to open the pill bottle and take the medication. Additional messages are triggered by the pill bottle when non-adherence is indicated (lack of bottle opening or no change in remaining pills), as well as when medication is skipped.
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Behavioral Intervention
Use smart pill bottle
Educational Intervention
Receives time-specific reminders and messages
Interventions
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Telemedicine
Participate in virtual visits with oncologist
Best Practice
Receive 4 in-office visits with oncologist
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Complete electronic survey
Behavioral Intervention
Use smart pill bottle
Educational Intervention
Receives time-specific reminders and messages
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Maysa Abu-Khaaf, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Jefferson Health - South Jersey
Washington Township, New Jersey, United States
Thomas Jefefrson University
Philadelphia, Pennsylvania, United States
Methodist Hospital
Philadelphia, Pennsylvania, United States
Jefferson Health - Northeast
Torresdale, Pennsylvania, United States
Jefferson Health - Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Countries
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Other Identifiers
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JT 11620
Identifier Type: OTHER
Identifier Source: secondary_id
18D.003
Identifier Type: -
Identifier Source: org_study_id
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