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

21 août 2026 mis à jour par: Vitaliy Poylin, Northwestern University

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

Aperçu de l'étude

Statut

Actif, ne recrute pas

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Illinois
      • Chicago, Illinois, États-Unis, 60011
        • Northwestern Memorial Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria: patient who will be undergoing new stoma creation

-

Exclusion Criteria:

  • history of previous stoma

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: standard stoma care
Expérimental: intervention
resiliency training is offered
resiliency training for study arm

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
City of Hope Quality of Life questionnaire for a Patient with an Ostomy (COH-QOL-Ostomy)
Délai: 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.
baseline - within 2 weeks of surgery, post operative - within 7 days after surgery, 3 and 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Survey
Délai: post operative - within 1 week of surgery, 3 and 6 months
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
post operative - within 1 week of surgery, 3 and 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2025

Achèvement primaire (Réel)

1 mai 2026

Achèvement de l'étude (Estimé)

1 janvier 2027

Dates d'inscription aux études

Première soumission

19 août 2026

Première soumission répondant aux critères de contrôle qualité

21 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • STU00221631

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

October 1, 2026 to September 30, 2027

Critères d'accès au partage IPD

information will be available upon request to study PI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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