A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Feasibility of PEP (percent of patients using videos/complete questionnaires)
研究概览
简要总结
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
详细描述
Patients will be randomized in a 2:1 ratio.
Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.
A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.
Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
- •Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
- •FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
- •FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
- •FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
- •De Gramont - 5-fluoruracil and leucovorin.
- •Ability to read and comprehend Hebrew language text.
- •Ability to see computer or cell phone screen (i.e., no visual impairment).
排除标准
- •Eastern Conference Oncology Group (ECOG) performance status greater than
- •Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- •Inability to read and comprehend Hebrew language text.
- •Current participation in a therapeutic clinical trial.
结局指标
主要结局
Feasibility of PEP (percent of patients using videos/complete questionnaires)
时间窗: 3 years
To assess the feasibility of implementing a PEP in the outpatient gastrointestinal malignancies service, at Sheba Medical Center, for patients undergoing active chemotherapy treatment. This outcome will be measured as percent of patients using the videos and percent of patients that complete the questionnaires.
次要结局
- Secondary clinical outcomes 1 (mean number of referrals)(3 years)
- Secondary clinical outcomes 2 (level of chemotoxicity)(3 years)
- Secondary clinical outcomes 3 (Quality of Life)(3 years)
- Secondary clinical outcomes 4 (treatment intensity and continuity)(3 years)