Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Recruitment rates
研究概览
简要总结
This pilot clinical trial studies survivorship care planning in supporting quality of life in ovarian cancer survivors following primary treatment. Survivorship care plans have the potential to empower patients and provide them with a plan of care following treatments. Survivorship care planning may support patient's overall well-being and quality of life after treatment of ovarian cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.
SECONDARY OBJECTIVES:
I. To develop the infrastructure and strategy for a larger comparative intervention study (National Cancer Institute [NCI] R01).
OUTLINE: Participants are assigned to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I, II, or III ovarian cancer
- •Ability to read or understand English
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Recruitment rates
时间窗: 2 months
Important information regarding recruitment for the subsequent larger trial will be provided including estimates of the number of contacts needed to produce a qualified participant, the percentage of those who are qualified and agree to participate, and a retention rate.
Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form
时间窗: 2 months
Quantitative and qualitative descriptive statistics will be analyzed using descriptive statistics and content analysis methods to determine satisfaction with the timing, content, and delivery of the intervention.
Percentage of attrition
时间窗: 2 months
Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate. Descriptive statistics will also be presented for percentage of attrition (based on number of patients who failed to complete the 2 months study. Reasons for attrition will also be documented.
Total retention
时间窗: 2 months
Descriptive statistics will be presented for the total retention.
次要结局
- Infrastructure for a larger comparative intervention study(2 months)