Clinical trial · Interventional
Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
Utilization of Patient Reported Outcomes Generated by Electronic Medical Record and Smart Pill Bottles With Follow up Telehealth Encounters to Improve Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients
- 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 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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage 0 Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Breast Cancer AJCC v7 | Malignant Breast Neoplasm |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Best Practice | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Telemedicine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (Standard of Care office Visits)
- description
- Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
- interventionNames
- Other: Best Practice
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm II (Standard of Care Office Visits, survey, telehealth)
- description
- 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.
- interventionNames
- Other: Telemedicine
- Other: Best Practice
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 illiterateReferences
Publications (0)
Data not yet available