Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
This pilot trial studies how well systems support mapping works in guiding self-management in stage I-III colorectal cancer survivors. Systems support mapping helps participants to see complex self-management activities on paper, which makes them more actionable. Behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of the systems support mapping (MAP) intervention in colorectal cancer survivors, as characterized by enrollment, intervention adherence, and retention rates.
SECONDARY OBJECTIVES:
I. To evaluate intervention acceptability as characterized by participant ratings.
II. To describe outcome variability to inform future studies. III. To identify multi-level contextual factors influencing self-management (SM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Diagnosed with stage I-III colorectal cancer
- •Within 2 years of completing active treatment for colorectal cancer
- •Cognitively able to complete interviews as judged by the study team
- •Able to understand, read and write English
排除标准
- •Declined participation in the study
结局指标
主要结局
Enrollment Rate
时间窗: Up to 1 year
To be calculated as the percent of eligible participants approached who agree to participate. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Participation Rate
时间窗: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
To be calculated as the percent of participants who complete the study intervention among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
Retention Rate
时间窗: Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later
To be calculated as the proportion of participants who complete the study measures among those enrolled. Will use one-sample tests of negative binomial probabilities and binomial proportions to compare rates of feasibility to hypothesized values. Rates will be summarized using point estimates and 95% confidence intervals.
次要结局
- Measures of Autonomy Assessed by Index of Autonomous Functioning(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Psychological Stress Assessed by Perceived Stress Scale(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Symptoms Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Profile 29(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Self-reported Ratings of Intervention Acceptability(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Self-efficacy for Managing Cancer - Chronic Disease Scale(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Self-Efficacy for Managing Symptoms - Patient Reported Outcomes Measurement Information System (PROMIS) Short Form(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- PROMIS - Relatedness Assessed by Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Qualitative Analysis of Systems Support Maps(Up to 1 year)
- Health Behaviors Assessed by Items on Tobacco Use(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Qualitative Assessment of Feasibility With Semi-structured Interviews(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Health Behaviors Assessed by Items on Use of Complementary Health Approaches(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Health Behaviors Assessed by Items on Physical Activity(Approximately 1.5-2 hours at baseline visit in clinic with a 2-week follow-up 2 weeks later)
- Qualitative Assessment of Acceptability With Semi-structured Interviews(Up to 1 year)
- Qualitative Assessment of Changes in Outcomes With Semi-structured Interviews(Up to 1 year)