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Ileostomy - StomaNCT07787637

Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners

A study testing resiliency training in people with Ileostomy - Stoma and Colostomy - Stoma, run by Northwestern University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

stoma creation is a traumatic experience for patients, effect on patients significant others and partners is not well understood. this study aims to evaluate effects of stoma creation on patients and partners and evaluate potential benefits of resiliency training on patients and partners quality of life Read more about this study

Who is it for?
Any age
What is being tested?
resiliency training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 1 Jan 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • history of previous stoma

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern Memorial Hospital

    Chicago, Illinois, 60011

Other trials in United States

About this study

Official title: Impact of Partner Support and Resiliency Training in New Stoma Patients

stoma creation is a traumatic experience for patients, effect on patients significant others and partners is not well understood. this study aims to evaluate effects of stoma creation on patients and partners and evaluate potential benefits of resiliency training on patients and partners quality of life

Read the 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.

Being tested
resiliency training
Keywords
stoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • resiliency trainingBehavioural

    resiliency training for study arm

Study groups in NCT07787637
Study groupRoleWhat they receive
standard stoma careNo interventionstandard stoma care
interventionExperimentalresiliency training is offered
Receives: Behavioral: resiliency training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. City of Hope Quality of Life questionnaire for a Patient with an Ostomy (COH-QOL-Ostomy)

    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.

    Measured: baseline - within 2 weeks of surgery, post operative - within 7 days after surgery, 3 and 6 months

Secondary outcomes (1)
  1. Survey

    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

    Measured: post operative - within 1 week of surgery, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start1 Jan 2025
  3. Primary completion1 May 2026
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
patient with new stomas and their partners are surveyed before and after stoma creation and resiliency training is undertaken for intervention group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07787637
Sponsor's protocol ID
STU00221631
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: de-ideitified data will be shared with other researches upon request. survey results will be available to researches outside study group for further analysis. we will share study protocol and all associated de-identified documents

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