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

Thomas Jefferson University

Status: Completed

Conditions: Stage III Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage I Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage II Breast Cancer AJCC v6 and v7; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage 0 Breast Cancer AJCC v6 and v7

Treatments: Other: Educational Intervention; Other: Survey Administration; Other: Best Practice; Other: Telemedicine; Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04054557

18D.003

JT 11620 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 3 patient groups

Arm I (Standard of Care office Visits)

Active Comparator group

Description:

Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Best Practice

Arm II (Standard of Care Office Visits, survey, telehealth)

Experimental group

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Telemedicine

Other: Best Practice

Other: Survey Administration

Arm III (Smart Pill Bottle, messaging)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Behavioral Intervention

Other: Questionnaire Administration

Other: Educational Intervention