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

Not Applicable

Active, not recruiting

• Conditions: Stage 0 Breast Cancer AJCC v6 and v7; Stage I 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; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage III Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7
• Interventions: Other: Telemedicine; Other: Questionnaire Administration; Other: Best Practice; Other: Quality-of-Life Assessment; Behavioral: Behavioral Intervention; Other: Educational Intervention; Other: Survey Administration

• Registration Number: NCT04054557
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-31
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-13
• Primary Completion: 2023-11-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Standard of Care office Visits)	Quality-of-Life Assessment	Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Arm I (Standard of Care office Visits)	Questionnaire Administration	Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Arm II (Standard of Care Office Visits, survey, telehealth)	Best Practice	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.
Arm II (Standard of Care Office Visits, survey, telehealth)	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.
Arm II (Standard of Care Office Visits, survey, telehealth)	Survey Administration	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.
Arm II (Standard of Care Office Visits, survey, telehealth)	Telemedicine	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.
Arm III (Smart Pill Bottle, messaging)	Questionnaire 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.
Arm III (Smart Pill Bottle, messaging)	Behavioral Intervention	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.
Arm I (Standard of Care office Visits)	Best Practice	Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Arm II (Standard of Care Office Visits, survey, telehealth)	Questionnaire Administration	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.
Arm III (Smart Pill Bottle, messaging)	Quality-of-Life Assessment	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.
Arm III (Smart Pill Bottle, messaging)	Educational Intervention	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.

Primary Outcome Measures

Name	Time	Method
Adherence to endocrine therapy (ET)	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with cancer care	At 12 months	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.
Quality of life assessment	1 year post intervention	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.
ET side effects	Up to one year	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.

Trial Locations

Locations (5)

Methodist Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Jefferson Health - Northeast; 🇺🇸 Torresdale, Pennsylvania, United States

Jefferson Health - Asplundh Cancer Pavilion; 🇺🇸 Willow Grove, Pennsylvania, United States

Jefferson Health - South Jersey; 🇺🇸 Washington Township, New Jersey, United States

Thomas Jefefrson University; 🇺🇸 Philadelphia, Pennsylvania, United States