Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Patient and family caregiver (FCG) participation
研究概览
简要总结
This phase II trial studies how well Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) provides patients and their caregivers information about ostomy and ostomy care. Periop-OSMT may help to understand patient preparedness to do ostomy self-care, confidence in doing ostomy self-care, knowledge of ostomy self-care, quality of life, mood, use of medical services, and financial burden.
详细描述
PRIMARY OBJECTIVE:
I. Assess the feasibility and acceptability of the Periop-OSMT as measured by the percentage of patients and support persons/family caregivers (FCGs) who agree to participate; complete >= 80% of the intervention; and report satisfaction with the intervention (through structured exit interviews).
SECONDARY OBJECTIVES:
I. Examine the patterns and trajectories for patient outcomes pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life (HRQOL), medical care utilization, and financial burden.
II. Examine patterns and trajectories for support person/FCG outcomes pre- and post-intervention, including quality of life (QOL).
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
- •PATIENT: Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary).
- •PATIENT: Able to read and understand English.
- •PATIENT: Patients scheduled for temporary ostomy procedures
- •SUPPORT PERSON/FCG: Family member/friend identified by the patient as the primary caregiver before and after surgery.
- •SUPPORT PERSON/FCG: Able to read and understand English.
- •Patients with all stages of disease are eligible for the study.
- •The study is open to anyone regardless of gender or ethnicity. Efforts are made to extend the accrual to a representative population.
排除标准
- •Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
结局指标
主要结局
Patient and family caregiver (FCG) participation
时间窗: Up to 24 months
Assessed by ratio of eligible participants (patient and FCGs) to those enrolled and those who decline participation, reasons for non-participation, number of scheduled study encounters completed, attrition rate between pre- and post-intervention, reasons for attrition/dropout, level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions, and the ratio of all participants to those who completed \>= 80% of the study.
次要结局
- Patient reported outcomes(Up to 6 months post-discharge)
- Acceptability of Perioperative Ostomy Self-Management Telehealth(Up to 24 months)
- Support person/FCG reported outcomes(Up to 6 months post-discharge)