NCT07787637

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Ileostomy - StomaColostomy - StomaUrostomy Patent

Keywords

stoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Survey

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

Study Arms (2)

standard stoma care

NO INTERVENTION

standard stoma care

intervention

EXPERIMENTAL

resiliency training is offered

Behavioral: resiliency training

Interventions

resiliency trainingBEHAVIORAL

resiliency training for study arm

intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • history of previous stoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60011, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: patient with new stomas and their partners are surveyed before and after stoma creation and resiliency training is undertaken for intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 26, 2026

Study Start

January 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
October 1, 2026 to September 30, 2027
Access Criteria
information will be available upon request to study PI

Locations

US(1)