An interventional study of Telemedicine and Best Practice in Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7 and Stage IA Breast Cancer AJCC v7, sponsored by Thomas Jefferson University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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 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.
142 studies on the registry are indexed under Breast Carcinoma In Situ; 26 are open to participants now.
This study's enrollment of 305 is above the median of 80 across 109 interventional studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Signed informed consent obtained prior to any study specific assessments and procedures
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
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
Exclusion Criteria:
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Other: Best Practice · Other: Questionnaire Administration · Other: Quality-of-Life Assessment
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.
Other: Telemedicine · Other: Best Practice · Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Other: Survey Administration
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.
Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Behavioral: Behavioral Intervention · Other: Educational Intervention
Participate in virtual visits with oncologist
Also known as: Telehealth, telemedicine
Receive 4 in-office visits with oncologist
Also known as: best practice, standard of care, standard therapy
Ancillary studies
Ancillary studies
Also known as: Quality of Life Assessment
Complete electronic survey
Use smart pill bottle
Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Treatment, Behavioral Interventions
Receives time-specific reminders and messages
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Adherence to endocrine therapy (ET)
ET is defined as the proportion of patients with filled prescriptions to cover \>= 80% of their ET doses for the year and pill diaries documenting receipt of \>= 80% of prescribed doses of ET for the year. ET medication adherence will be evaluated by pill diary collected at each quarterly clinic visit.
Time frame: Up to one year
Quality of life assessment
Patients will fill out the Functional Assessment of cancer Therapy-Endocrine Subscale (FACT-ES) at initiation of trial, and then at each of the quarterly clinic visits for Arm B and on paper for patients on Arm A. The FACT-ES, has two sections each of which will be evaluated separately. The first section, FACT-G, will be used as a measure of general quality of life. It consists of 27 items, each scored 0 to 4. Scores range from 0 to 108 with higher scores indicating worse quality of life.
Time frame: 1 year post intervention
ET side effects
Patients will fill out the Functional Assessment of cancer Therapy-Endocrine Subscale (FACT-ES) at initiation of trial, and then at each of the quarterly clinic visits. The FACT-ES, has two sections each of which will be evaluated separately. The second section of the FACT-ES will be used as a measure of specific side effects of endocrine therapy. It consists of 19 items scored 0 to 4 with scores ranging from 0 to 76. A higher score indicates worse side effects. The FACT-ES has established validity and reliability in breast cancer patients.
Time frame: Up to one year
Satisfaction with cancer care
This will be evaluated using a modified version of the Patient Satisfaction With Cancer Care Scale (PSCCS). The modified scale contains 14 items, each rated on a 5-point scale ranging from strongly agree (5) to strongly disagree (1). Scores range from 14 to 70 with higher scores indicating greater satisfaction.
Time frame: At 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Jefferson University