CompletedNot Applicable

Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence

United States305 participantsStarted 2019-07-31

Plain-language 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 receptor positive) stage 0-III breast cancer who have underwent surgery. Telehealth is an approach to care that uses digital information and communication tools to manage health and well-being. Participants interact with their health care providers via a video chat on a computer or smart phone. Telehealth may help identify the effects of treatment on participants with breast cancer who have underwent surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence to endocrine therapy (ET)

Timeframe: Up to one year

Trial details

NCT IDNCT04054557

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-06

View on ClinicalTrials.gov More Stage 0 Breast Cancer AJCC v6 and v7 trials