Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Impact of Partner Support and Resiliency Training in New Stoma Patients
研究概览
详细说明
Approximately 100,000 people in the United States undergo operations that result in a colostomy or ileostomy every year. The implications of having a new ostomy can include physical side effects (short and long-term), impact on activities of daily living (ADL's) and relationships as well as major psychosocial impact that a stoma can have on both the patient and their partners. Need for a stoma has been associated with drastic effect on patient's quality of life in multiple studies, however, effects on partner's life have never been fully. The amount of help spouses provide with daily stoma care activity varies providing all ostomy care to never or rarely helping their partners with stoma care and can have significant effect on adaptability to new stoma.1 The changes experienced by the ostomy patient are shared by the couple, and both parties must work toward adapting to the condition.
Studying effects of stoma can be challenging, due to required length of studies to capture the quality measures over time and after significant time has passed since the ostomy creation. Depending on the indication for the ostomy, some patients may have it reversed within months while it is permanent for other patients. In addition to the variety of patients with ostomies, quality of life studies are challenged by the length of time to complete surveys, focus groups, and interviews. A few available studies including The City of Hope Quality of Life: Ostomy Instrument tool has been validated and used to further understand how an ostomy is affecting a patient in order to provide improved care. Another tool, the Ostomy Comprehensive Health and Life Assessment Survey, was utilized to study impacts on patients recovery after ostomy surgery and found that a stable spouse or partner was predictive of positive life satisfaction scores.2. Additional studies demonstrated further need for education and follow up by finding several negative impacts of a stoma on patients' 3 Current guidelines recommend pre operative education and stoma marking as well as small group support as measures shown to improve coping with post operative stoma. 4 Patients with high levels of resilience are able to use the problems they face in a positive manner subsequently experience fewer depressive episodes and adapt better to their disease. Resilience refers to "a dynamic process encompassing positive adaptation within the context of significant adversity".5 Resilience training "is a prepared (structured and planned) activity aimed to embrace and gain a positive mindset and experience in stressful and difficult emulated situations ." 6 Resilience training has been shown to foster enhanced coping to changes in health, decrease risk for depression and anxiety, and increase engagement in positive self-management behaviors, in the context of how patients cope with IBD more broadly. There is limited research examining the role of resilience in ostomy adaptation. One cross sectional study found that patients with Crohn's disease and an ostomy with higher resilience had lower depressive symptoms. To our knowledge, no studies are available to evaluate effect of pre operative resilience training and resilience on ostomate or their partners. Training techniques may vary but include common techniques to develop skills for emotional regulation, choosing to be realistically optimistic about the future, setting achievable goals, realizing that which is under and now under our own control and learning to thrive in difficult situations.7 Resiliency training methods may include structured courses, videos, journaling, meditation and one and one counseling.
Hypothesis Standardized education and resilience training will help ostomy patients and their partners to better cope with their new stoma and improve quality of life.
Aims Aims 1: Compare effects of standardized patient and partner pre operative and resiliency training on patient and partner quality of life.
Aim 2: Evaluate effects of standardize training on rates of readmission, emergency room and clinic visits and complications
Method Northwestern Medicine Digestive Health Center has a very busy gastrointestinal surgery practice and performs approximately 175 ostomy surgeries each year. These are done for a variety of conditions including colon or rectal cancer, inflammatory bowel disease and diverticulitis. Patients undergoing planned ileostomies and colostomies, whenever temporary and permanent ostomy patients will be recruited.. Patients being planned for ostomy will be identified from clinic and inpatient schedules. If agreed to participate, baseline surveys will be administered and patients will be randomized between standard enhanced pre operative training. Standard training will include current pre operative visit with wound and stoma nurses (partner participation is allowed, but not required) In enhanced group, partner participation will be strongly encouraged at all steps and they will undergo resiliency training as well. Basic resiliency training will be included with standardized ostomy education and will include written materials, videos, and activities that the patient will be given to complete on their own.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60011
- Northwestern Memorial Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria: patient who will be undergoing new stoma creation
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Exclusion Criteria:
- history of previous stoma
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:standard stoma care
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实验性的:intervention
resiliency training is offered
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resiliency training for study arm
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
City of Hope Quality of Life questionnaire for a Patient with an Ostomy (COH-QOL-Ostomy)
大体时间:baseline - within 2 weeks of surgery, post operative - within 7 days after surgery, 3 and 6 months
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The City of Hope Quality of Life-Ostomy Questionnaire (COH-QOL-Ostomy) is a specialized, multidimensional self-report tool designed to measure health-related quality of life in adult patients with intestinal or urinary ostomies.
consists of 43 specific items that are scored 0 to 10. higher score means better qualify of life.
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baseline - within 2 weeks of surgery, post operative - within 7 days after surgery, 3 and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Survey
大体时间:post operative - within 1 week of surgery, 3 and 6 months
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resiliency scale for inflammatory bowel disease (RISE-IBD).
this is 14-item tool used to measure psychological resiliency in patients with inflammatory bowel disease.
lower score means worse resiliency and higher score means better resiliency
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post operative - within 1 week of surgery, 3 and 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- STU00221631
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
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