A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Patient Experience Comparison
研究概览
简要总结
This research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely
详细描述
This study is a prospective randomized trial of telemedicine (TM) versus face-to-face (F2F) visits for follow up care of patients with either early-stage breast or prostate cancer.
This study does not involve investigational drugs or devices but does involve survey data collection from participants about their experiences of care.
After an initial in-person routine visit, participants will be randomly assigned to either telemedicine or face-to-face care delivery for their next routine visit.
It is anticipated participants will be in the study for about 6 months depending on the timing of their routine care appointments.
It is expected that 360 people will take part in this research study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •For breast cancer participants: Early-stage breast cancer defined as Stages I-IIIA at diagnosis or localized prostate cancer defined as Stages I-III
- •For breast cancer participants: participant has completed definitive treatment for early stage breast cancer including surgery, radiation, chemotherapy, anti-HER2 antibody treatment. Participant may or may not be taking oral anti-estrogen treatment such as tamoxifen or an aromatase inhibitor
- •For prostate cancer participants: participant is on active surveillance or has undergone definitive surgery for localized prostate cancer
- •Participant is on a surveillance follow up visit schedule occurring at every three to seven month intervals
- •Willingness and ability to use Patient Gateway portal
- •Participant has access to an electronic device that can support a video and audio virtual visit platform (for example, laptop computer, desktop computer, smart phone)
- •Participants can be women or men
- •Age ≥ 18 years
排除标准
- •Patients whose next visit requires cytotoxic chemotherapy, radiation therapy, anti-HER2 antibody therapy or investigational cancer agents are ineligible
- •Patients with distant metastatic breast cancer
- •Patients with locally advanced or metastatic prostate cancer
- •Patients treated by radiation therapy for prostate cancer
- •Patients whose next visit requires a prostate biopsy
- •Prisoners
- •Non-English speaking patients (non-English speaking patients will be excluded from the trial given the challenges of delivering telemedicine with the use of medical interpreters. There are also logistical challenges in obtaining the study endpoints, which are largely survey based, with non-English speakers as well as the possibility that study endpoints will be influenced by the presence of a medical interpreter during a visit).
结局指标
主要结局
Patient Experience Comparison
时间窗: Up to 6 months
Compare early-stage breast and early stage prostate cancer patients' experiences with a one-time Telemedicine (TM) versus Face to Face (F2F) follow up visit for routine oncologic surveillance
次要结局
- Indirect Health Care Costs Comparison(Up to 6 months)
- Patient preference Comparison(Up to 6 months)
- Health system use Comparison(Two weeks after study visit)
- Clinician Preference(Up to 6 months)
- Clinician Experience Comparison(Up to 6 months)
- Symptom severity-prostate cancer patients Comparison(Up to 6 months)
研究者
Christopher Manz, MD
Principal Investigator
Dana-Farber Cancer Institute