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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 5
- 主要终点
- Adherence to endocrine therapy (ET)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •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
研究组 & 干预措施
Arm II (Standard of Care Office Visits, survey, telehealth)
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.
干预措施: Telemedicine (Other)
Arm II (Standard of Care Office Visits, survey, telehealth)
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.
干预措施: Best Practice (Other)
Arm II (Standard of Care Office Visits, survey, telehealth)
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.
干预措施: Questionnaire Administration (Other)
Arm II (Standard of Care Office Visits, survey, telehealth)
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.
干预措施: Quality-of-Life Assessment (Other)
Arm I (Standard of Care office Visits)
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
干预措施: Best Practice (Other)
Arm I (Standard of Care office Visits)
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
干预措施: Questionnaire Administration (Other)
Arm I (Standard of Care office Visits)
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
干预措施: Quality-of-Life Assessment (Other)
Arm II (Standard of Care Office Visits, survey, telehealth)
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.
干预措施: Survey Administration (Other)
Arm III (Smart Pill Bottle, messaging)
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.
干预措施: Questionnaire Administration (Other)
Arm III (Smart Pill Bottle, messaging)
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.
干预措施: Quality-of-Life Assessment (Other)
Arm III (Smart Pill Bottle, messaging)
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.
干预措施: Behavioral Intervention (Behavioral)
Arm III (Smart Pill Bottle, messaging)
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.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Adherence to endocrine therapy (ET)
时间窗: Up to one year
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.
次要结局
- Satisfaction with cancer care(At 12 months)
- Quality of life assessment(1 year post intervention)
- ET side effects(Up to one year)