NCT04337203已完成不适用
SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Patients Enrolled Out of Those Electronically Referred
研究概览
简要总结
The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
详细描述
Primary Objectives:
• To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize >30% of patients e-referred to SHARE-S will enroll.
Secondary Objectives:
- To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity).
- To describe service outcome variability to inform future studies. Investigators will assess service outcomes relevant to Commission on Cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. We will also assess safety and perceived patient-centeredness of care.
- To describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care).
- To evaluate the Implementation Program we will assess key milestones and processes for this pilot study of the Implementation Stage measured at the clinic level.
- To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded.
- To examine how study results vary by cancer type.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •Documented or planned cancer survivorship visit
- •Have a texting enabled telephone
- •Cognitively able to complete study procedures as judged by the study team
- •Able to understand, read and write English
- •Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.
- •Exclusion Criteria
- •Declined participation in the study
排除标准
- 未提供
结局指标
主要结局
Number of Patients Enrolled Out of Those Electronically Referred
时间窗: 1 year, 8 months
Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.
次要结局
- Participant Adherence to Coaching Sessions(1 year, 8 months)
- Number of Coaching Sessions Completed(1 year, 8 months)
- Frequency of Adverse Events(Up to 30 days after the final intervention session.)
- Acceptability of Intervention Measure(Up to 30 days after the final intervention session.)
- Number of Participants Adhering to Text Responses(1 year, 8 months)
- Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review](1 year, 8 months)
- Appropriateness of Intervention Measure(Up to 30 days after the final intervention session.)
- Feasibility of Intervention Measure(Up to 30 days after the final intervention session.)
- Retention Rates(Up to 30 days after the final intervention session.)
- Length of Coaching Sessions(Up to 30 days after the final intervention session.)
- 36-Item Short Form Survey (SF-36)(At baseline and up to 30 days after the final intervention session.)
- Index of Autonomous Functioning - Self Congruence Subscale Only(At baseline and up to 30 days after the final intervention session.)
- Health Behaviors Questionnaire - Physical Activity(At baseline and up to 30 days after the final intervention session.)
- Health Behaviors Questionnaire - Fruit and Vegetable Intake(At baseline and up to 30 days after the final intervention session.)
- Number of Participants Enrolled Per Month(1 year, 8 months)
- Total Number of Patients Enrolled(1 year, 8 months)
- HEAL Patient-Provider Connection(Up to 30 days after the final intervention session.)
- Health Behaviors Questionnaire - Mindfulness Practice(At baseline and up to 30 days after the final intervention session.)
- Health Behaviors Questionnaire - Tobacco Use(At baseline and up to 30 days after the final intervention session.)
- Patient-Reported Health Outcomes PROMIS Profile 29(At baseline and up to 30 days after the final intervention session.)
- Health Behaviors Questionnaire - Alcohol Use Disorder(At baseline and up to 30 days after the final intervention session.)
- Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire(At baseline and up to 30 days after the final intervention session.)
- Self-Efficacy to Manage Chronic Disease Questionnaire(At baseline and up to 30 days after the final intervention session.)
- Engagement With the Survivorship Care Plan(1 year, 8 months)
- Satisfaction of Care(Up to 30 days after the final intervention session.)
研究者
研究点 (2)
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