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

NCT04054557 | Completed DMC

• 2 other identifiers: 18D.003JT 11620
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 5

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.

Conditions

Stage IA Breast Cancer AJCC v7; 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 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

Outcome Measures

Primary Outcomes (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.

  Up to one year

Secondary Outcomes (3)

• Quality of life assessment

  1 year post intervention

• ET side effects

  Up to one year

• Satisfaction with cancer care

  At 12 months

Study Arms (3)

Arm I (Standard of Care office Visits)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

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

EXPERIMENTAL

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.

Other: Telemedicine; Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Arm III (Smart Pill Bottle, messaging)

EXPERIMENTAL

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.

Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Behavioral: Behavioral Intervention; Other: Educational Intervention

Interventions

Telemedicine OTHER

Participate in virtual visits with oncologist

Also known as: Telehealth, telemedicine

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

Best Practice OTHER

Receive 4 in-office visits with oncologist

Also known as: best practice, standard of care, standard therapy

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

Questionnaire Administration OTHER

Ancillary studies

Arm I (Standard of Care office Visits); Arm II (Standard of Care Office Visits, survey, telehealth); Arm III (Smart Pill Bottle, messaging)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Standard of Care office Visits); Arm II (Standard of Care Office Visits, survey, telehealth); Arm III (Smart Pill Bottle, messaging)

Survey Administration OTHER

Complete electronic survey

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

Behavioral Intervention BEHAVIORAL

Use smart pill bottle

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Treatment, Behavioral Interventions

Arm III (Smart Pill Bottle, messaging)

Educational Intervention OTHER

Receives time-specific reminders and messages

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm III (Smart Pill Bottle, messaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (5)

Jefferson Health - South Jersey

Washington Township, New Jersey, 08080, United States

Location

Thomas Jefefrson University

Philadelphia, Pennsylvania, 19107, United States

Location

Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

Jefferson Health - Northeast

Torresdale, Pennsylvania, 19114, United States

Location

Jefferson Health - Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Telemedicine; Practice Guidelines as Topic; Standard of Care; Behavior Therapy; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Psychotherapy; Behavioral Disciplines and Activities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Maysa Abu-Khaaf, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: July 31, 2019
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)