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| ID | Type | Description | Link |
|---|---|---|---|
| JT 11620 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Participate in virtual visits with oncologist |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Maysa Abu-Khaaf, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Health - South Jersey | Washington Township | New Jersey | 08080 | United States | ||
| Thomas Jefefrson University |
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| Best Practice | Other | Receive 4 in-office visits with oncologist |
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| Questionnaire Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Survey Administration | Other | Complete electronic survey |
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| Behavioral Intervention | Behavioral | Use smart pill bottle |
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| Educational Intervention | Other | Receives time-specific reminders and messages |
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| 1 year post intervention |
| 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. | Up to one year |
| 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. | At 12 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Methodist Hospital | Philadelphia | Pennsylvania | 19148 | United States |
| Jefferson Health - Northeast | Torresdale | Pennsylvania | 19114 | United States |
| Jefferson Health - Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D001521 | Behavior Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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