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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    285
  • sponsor
    Thomas Jefferson University
Updated on 11 September 2021
cancer
breast surgery
estrogen
endocrine therapy
progesterone
hormone therapy
progesterone receptor
estrogen receptor
breast cancer staging

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.

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.

Details
Condition Estrogen Receptor Positive Breast Cancer, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, ER+ Breast Cancer, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Progesterone Receptor Positive Breast Cancer, estrogen receptor-positive breast cancer, non-invasive breast carcinoma
Treatment questionnaire administration, quality-of-life assessment, educational intervention, telemedicine, survey administration, Best Practice, behavioral intervention
Clinical Study IdentifierNCT04054557
SponsorThomas Jefferson University
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

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
Pts who are non-English speaking and English illiterate
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)
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