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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
What is being tested?
Telemedicine, Best Practice and Questionnaire Administration
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

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

Other trials in United States

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:

  1. 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:

  1. 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.

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 groups in NCT04054557
Study groupRoleWhat they receive
Arm I (Standard of Care office Visits)Active comparatorParticipants 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)ExperimentalPatients 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)ExperimentalPatients 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted13 Aug 2019
  2. Study start31 Jul 2019
  3. Primary completion6 Dec 2024
  4. Study completion6 Dec 2024

Resources

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)
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

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