Stage 0 Breast Cancer AJCC v6 and v7NCT04054557
Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
A study testing Telemedicine, Best Practice and Questionnaire Administration in people with Stage 0 Breast Cancer AJCC v6 and v7 and Stage I Breast Cancer AJCC v7, run by Thomas Jefferson University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
- What is being tested?
- Telemedicine, Best Practice and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jul 2019to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Thomas Jefefrson University
Philadelphia, Pennsylvania, 19107
Methodist Hospital
Philadelphia, Pennsylvania, 19148
Jefferson Health - Northeast
Torresdale, Pennsylvania, 19114
Jefferson Health - South Jersey
Washington Township, New Jersey, 08080
Jefferson Health - Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7
- Being tested
- Telemedicine, Best Practice, Questionnaire Administration, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Telehealth, telemedicine
Participate in virtual visits with oncologist
Best PracticeOther
Also called best practice, standard of care, standard therapy
Receive 4 in-office visits with oncologist
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Complete electronic survey
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Use smart pill bottle
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention
Receives time-specific reminders and messages
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Standard of Care office Visits) | Active comparator | Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year. Receives: Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
| Arm II (Standard of Care Office Visits, survey, telehealth) | Experimental | 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. Receives: Other: Telemedicine; Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm III (Smart Pill Bottle, messaging) | Experimental | 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. Receives: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Behavioral: Behavioral Intervention; Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start31 Jul 2019
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 0 Breast Cancer AJCC v6 and v7Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maysa Abu-Khaaf, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054557
- Sponsor's protocol ID
- 18D.003
- Other IDs
- JT 11620
- Status last verified
- Feb 2026
- First submitted
- 8 Aug 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04054557
- Acronym / sponsor ID
- 18D.003
- Conditions
- Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (Standard of Care office Visits) | Active comparator | Other: Best Practice, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentParticipants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year. |
| Arm II (Standard of Care Office Visits, survey, telehealth) | Experimental | Other: Telemedicine, Other: Best Practice, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients 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. |
| Arm III (Smart Pill Bottle, messaging) | Experimental | Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Behavioral: Behavioral Intervention, Other: Educational InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Signed informed consent obtained prior to any study specific assessments and procedures
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAlso: Telehealth, telemedicineParticipate in virtual visits with oncologist | Other | Arm II (Standard of Care Office Visits, survey, telehealth) |
| Best PracticeAlso: best practice, standard of care, standard therapyReceive 4 in-office visits with oncologist | Other | Arm I (Standard of Care office Visits), Arm II (Standard of Care Office Visits, survey, telehealth) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Standard of Care office Visits), Arm II (Standard of Care Office Visits, survey, telehealth), Arm III (Smart Pill Bottle, messaging) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Standard of Care office Visits), Arm II (Standard of Care Office Visits, survey, telehealth), Arm III (Smart Pill Bottle, messaging) |
| Survey AdministrationComplete electronic survey | Other | Arm II (Standard of Care Office Visits, survey, telehealth) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyUse smart pill bottle | Behavioural | Arm III (Smart Pill Bottle, messaging) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, InterventionReceives time-specific reminders and messages | Other | Arm III (Smart Pill Bottle, messaging) |
Primary outcome
Adherence to endocrine therapy (ET)
Time frame: Up to one year
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.
3 secondary outcomes
Quality of life assessment
Time frame: 1 year post intervention
ET side effects
Time frame: Up to one year
Satisfaction with cancer care
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Stage 0 Breast Cancer AJCC v6 and v7
Active, not recruitingPhase 3
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
Breast Carcinoma In Situ, Invasive Breast Carcinoma
Active, not recruitingPhase 1
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Breast Carcinoma In Situ, Breast Ductal Carcinoma In Situ
Active, not recruitingPhase 3
Breast Cancer WEight Loss Study (BWEL Study)
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Active, not recruitingPhase 2
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma
Active, not recruitingPhase 2
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
Breast Adenocarcinoma, Ductal Breast Carcinoma In Situ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maysa Abu-Khaaf, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine, Best Practice and Questionnaire Administration in people with Stage 0 Breast Cancer AJCC v6 and v7 and Stage I Breast Cancer AJCC v7, run by Thomas Jefferson University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to endocrine therapy (ET) (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.