Clinical trial NCT04054557: Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Stage IIB 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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to endocrine therapy (ET)
timeFrame: Up to one year
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 1 year post intervention
measure: ET side effects
timeFrame: Up to one year
measure: Satisfaction with cancer care
timeFrame: At 12 months
Other outcomes:
Locations:
city: Washington Township
country: United States
facility: Jefferson Health - South Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefefrson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Methodist Hospital
state: Pennsylvania
city: Torresdale
country: United States
facility: Jefferson Health - Northeast
state: Pennsylvania
city: Willow Grove
country: United States
facility: Jefferson Health - Asplundh Cancer Pavilion
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Maysa Abu-Khaaf, MD
role: PRINCIPAL_INVESTIGATOR
References: