Skip to main content
Clinical Trials/NCT07369219
NCT07369219
Active, not recruiting
Not Applicable

Investigating the Effect of a Care Intervention Implemented in Stoma Patients Receiving Care Based on Enhanced Recovery Propositions on Patient Outcomes and Home Care Management: A Mixed Methods Study

Bahçeşehir University1 site in 1 country98 target enrollmentStarted: May 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Bahçeşehir University
Enrollment
98
Locations
1
Primary Endpoint
KATZ Activities of Daily Living (ADL) Scale

Overview

Brief Summary

Colorectal cancer is one of the most common cancers in the world and affects a large number of people every year. Surgical intervention and neoadjuvant treatment are mostly preferred for treatment, and temporary or permanent stoma is often opened. Complications that are difficult to manage may arise due to the treatment itself, the disease or the stoma. Complications that are difficult to manage carry a high risk of re-hospitalization. Patients receive limited support during the transition from hospital to home and at home. Patients and their relatives are often alone in home care management until the routine check-up process. Especially patients who are not well prepared for discharge and inadequate in stoma management may not know how to apply care practices during this period at home and the situations they should pay attention to in case of complications. Conditions that can be managed well in the hospital may get out of control when the patient goes home and may cause unplanned re-admissions to the hospital if there is not enough follow-up. Inadequate patient follow-up after surgery may cause patients to be anxious and therefore may cause re-hospitalization due to the inability to manage the home care process in a controlled manner.

Although it is known that the duration of hospital stay is shortened with advanced improvement suggestions, different results are remarkable in studies on hospital readmissions, reoperations, developing complications and survival. Since the care needs of patients after surgical intervention vary, there is a need for individualized and evidence-supported suggestions. Currently, advanced improvement suggestions do not include the answer to the question and roadmap of how patients will be followed at home after discharge. The surgical journey should be followed with comprehensive care application steps that are a continuation of evidence-based practices that start from the moment the patient is admitted to the hospital, making them feel that they are not alone during the recovery process they will spend at home after being discharged. The provision of home care management is important for the continuity of the recovery process. Although there are various application models used in the literature for the purpose of preparing and following up on the discharge process, no study has been found that focuses on comprehensive discharge preparation and home care management of stoma patients receiving care in line with advanced recovery recommendations. In this sense, it is believed that the study will be a fundamental study in terms of developing a fourth phase, post-discharge home care management, which is the continuation of the pre-, intra- and post-operative process as included in advanced recovery guidelines and a gap in the literature.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Agree to participate in the study
  • Be 18 years of age or older
  • Be able to communicate in Turkish
  • Have no visual or hearing impairment
  • Elective colorectal surgery in line with advanced treatment recommendations Having a stoma opened for the first time due to colorectal cancer

Exclusion Criteria

  • patients who did not meet the inclusion criteria

Arms & Interventions

Control Group

Active Comparator

Routine hospital discharge education, usual stoma care follow-up, and standard postoperative monitoring without the additional structured education booklet or planned telephone follow-up.

Intervention: Standard maintenance therapy (Other)

intervention group

Experimental

A structured discharge education program supported with a home-care booklet and scheduled telephone follow-up at postoperative days 3, 7, 10, and 30.

Intervention: Educational intervention (Behavioral)

Outcomes

Primary Outcomes

KATZ Activities of Daily Living (ADL) Scale

Time Frame: Baseline (pre-discharge) and postoperative day 30

If the individual can do their ADL independently, they are given 3 points, if they are partially assisted, they are given 2 points, if they cannot do it at all, they are given 1 point and the evaluation is made accordingly. In the evaluation made according to this scale, 0-6 points are evaluated as dependent, 7-12 points as partially dependent, and 13-18 points as independent. Accordingly, as the score obtained from the scale increases, dependency decreases.

EORTC QLQ-C30 Quality of Life Scale

Time Frame: Baseline (pre-discharge) and postoperative day 30

The lowest total score that patients can get from the functional score, symptom score and general health score is 0, and the highest score is 100. A high score from the functional scales indicates a healthy functional level, a high score from the general health status scale indicates a high quality of life, and a high score from the symptom scale indicates that symptoms are experienced intensely and the level of the problem is high.

Stoma-Self-Efficacy Scale

Time Frame: Baseline (pre-discharge) and postoperative day 30

The total score of the scale ranges from 22 to 110, with higher scores indicating increased self-efficacy levels of patients.

Readiness for Discharge Scale

Time Frame: Up to 30 days after the patient's hospitalization date.

If the scale dimensions score was ≥7, the patient was considered ready for discharge, and if it was \<7, it was considered not ready.

Secondary Outcomes

  • Day of hospital stay(Up to 30 days after the patient's hospitalization date.)
  • complications(Up to postoperative day 30)
  • Readmisson(Within 30 days after discharge)

Investigators

Sponsor
Bahçeşehir University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Özlem Kıvanç

PhD student

Bahçeşehir University

Study Sites (1)

Loading locations...

Similar Trials