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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60011
- Northwestern Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: patient who will be undergoing new stoma creation
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Exclusion Criteria:
- history of previous stoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: standard stoma care
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Experimental: intervention
resiliency training is offered
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resiliency training for study arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
City of Hope Quality of Life questionnaire for a Patient with an Ostomy (COH-QOL-Ostomy)
Time Frame: baseline - within 2 weeks of surgery, post operative - within 7 days after surgery, 3 and 6 months
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU00221631
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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