Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient satisfaction with care delivered
研究概览
简要总结
This phase IV trial compares patient satisfaction with telehealth versus in-person neuro-oncology assessments among glioma patients receiving oral chemotherapy. Gliomas are the most common primary central nervous system cancer and are associated with a high symptom burden, such as drowsiness, fatigue, memory difficulty, and difficulty communicating. Care at a high volume center is associated with an overall survival benefit, however, many patients may have physical or financial difficulties preventing access to these centers. Telehealth visits use computers, cameras, videoconferencing, the internet, satellite, and wireless communications to deliver healthcare, while in-person visits require the interaction to take place in the physical presence of someone else. Telehealth neuro-oncology assessments may be preferable compared to in-person assessments in glioma patients receiving oral chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. Assess patient satisfaction with care delivered as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments.
SECONDARY OBJECTIVES:
I. Assess completion rate of planned oral chemotherapy among patients with glioma within 28 days of telehealth visits compared to within 28 days of in-person visits.
II. Assess preference for telehealth versus in-person neuro-oncologic evaluations among patients with glioma receiving oral chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma (GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are eligible
- •Patients eligible to receive temozolomide as standard of care adjuvant therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60
- •Expected survival ≥ 6 months in the opinion of treatment team
- •Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
- •Participants who do not have devices that will permit telehealth visits will be provided such tablet devices to facilitate appointments for the duration of the study
- •Participants who do not have financial resources to travel for in-person visits will be provided assistance for cost of travel
- •Ability to complete patient experience surveys by the participant with or without assistance from their caregiver
排除标准
- •Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
- •Pregnant or nursing, imprisoned, or lacking capacity for understanding
- •Unable to swallow tablets or at risk for impaired absorption of oral medication
- •Known hypersensitivity or allergy to temozolomide
研究组 & 干预措施
Health services research (temozolomide, telehealth, in-person)
Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.
干预措施: Assessment (Behavioral)
Health services research (temozolomide, telehealth, in-person)
Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.
干预措施: Questionnaire Administration (Other)
Health services research (temozolomide, telehealth, in-person)
Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.
干预措施: Telemedicine Visit (Other)
Health services research (temozolomide, telehealth, in-person)
Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Patient satisfaction with care delivered
时间窗: Up to 6 months
Satisfaction will be measured using Press-Ganey survey scores. Scores following each cycle of chemotherapy will be compared between alternating telehealth and in-person visits. The mean score associated with the telehealth visits versus (vs.) the in-person visits will be calculated for each patient. Potential patterns of changes associated with these scores over time will be graphically evaluated. Repeated measures mixed effects models will be used to further evaluate potential influence of a time element with the satisfaction scores for telehealth vs. in-person assessments.
次要结局
- Completion rate of planned oral chemotherapy(Within 28 days of telehealth or in-person visits and up to 6 months)
- Preference for telehealth vs. in-person neuro-oncologic evaluations(Up to 6 months)
- Acute care utilization days(Within 28 days of telehealth or in-person visits, up to 6 months)
- Neurologic impairment - NANO(Up to 6 months)
- Change in quality of life - EORTC QLQ-C30(Up to 6 months)