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

Primary Purpose

Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Best Practice
Questionnaire Administration
Quality-of-Life Assessment
Survey Administration
Behavioral Intervention
Educational Intervention
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage 0 Breast Cancer AJCC v6 and v7

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jefferson Health - South JerseyRecruiting
  • Thomas Jefefrson UniversityRecruiting
  • Methodist Hospital
  • Jefferson Health - NortheastRecruiting
  • Jefferson Health - Asplundh Cancer PavilionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm I (Standard of Care office Visits)

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

Arm III (Smart Pill Bottle, messaging)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life
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
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.
Satisfaction with cancer care
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.

Full Information

First Posted
August 8, 2019
Last Updated
October 18, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04054557
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Standard of Care office Visits)
Arm Type
Active Comparator
Arm Description
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Arm Title
Arm II (Standard of Care Office Visits, survey, telehealth)
Arm Type
Experimental
Arm 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.
Arm Title
Arm III (Smart Pill Bottle, messaging)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Other Intervention Name(s)
Telehealth, telemedicine
Intervention Description
Participate in virtual visits with oncologist
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
best practice, standard of care, standard therapy
Intervention Description
Receive 4 in-office visits with oncologist
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete electronic survey
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Treatment, Behavioral Interventions
Intervention Description
Use smart pill bottle
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receives time-specific reminders and messages
Primary Outcome Measure Information:
Title
Adherence to endocrine therapy (ET)
Description
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.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
Up to one year
Title
ET side effects
Description
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.
Time Frame
Up to one year
Title
Satisfaction with cancer care
Description
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.
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maysa Abu-Khalaf, MD
Phone
215-503-5088
Email
maysa.abu-khalaf@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maysa Abu-Khaaf, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Health - South Jersey
City
Washington Township
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maysa Abu-Khalaf, MD
Phone
215-503-5088
Facility Name
Thomas Jefefrson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maysa Abu-Khalaf, MD
Phone
215-503-5088
Email
maysa.abu-khalaf@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Maysa Abu-Khalaf, MD
Facility Name
Methodist Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Zibelli, MD
Phone
215-955-8874
Email
Allison.Zibelli@jefferson.edu
Facility Name
Jefferson Health - Northeast
City
Torresdale
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania Nolano, MD
Phone
215-481-4000
Email
Stefania.Nolano@jefferson.edu
Facility Name
Jefferson Health - Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Zibelli, MD
Phone
215-955-8874
Email
Allison.Zibelli@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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