Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy

NCT03681821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-09-24

No results posted yet for this study

Summary

Colorectal cancer (CRC) is one of the most commonly diagnosed cancers worldwide. The main treatment approach is radical surgery, and the auxiliary treatment may be chemotherapy, radiotherapy, immunotherapy and other supportive therapies, which can increase the resection rate, reduce the recurrence rate, and improve the survival rate. Abdominoperineal resection with an ostomy and the formation of a permanent ostomy continue to be the primary and radical surgical approaches for many patients with rectal cancer, which results in the loss of defecation control function.

Although ostomy-related surgery is a life-saving procedure in most cases, it inevitably elicits some complex and lifelong consequences, such as uncontrolled gas and stool emissions, disturbed patients' body images, and effects their social and sexual lives, which place heavy pressure on ostomy self-management.

Some studies have revealed the various ways that patients' lives are affected by their stoma, including changes to their quality of life, body image, and social life, requiring coping and practical adjustments. Others have shown that not enough attention has been paid to patients' self-management abilities, with most care being provided by nurses or caregivers, leaving little opportunities for patients to manage on their own. Consequently, their self-management ability after discharge remains weak, especially their related knowledge and skills. Studies have shown that 33.0-80.4% of patients with an ostomy cannot cope with the problems encountered in ostomy care.

Many scholars focused on the ability of early self-management in patients with an ostomy after discharge, and there were several issues in the field of stoma nursing care, such as insufficient discharge preparedness because of shortened hospital stays and a lack of systematic acquisition of related knowledge and skills. Others highlighted the paucity of attention paid to the post-discharge needs of patients with a stoma and a lack of formal training for follow-up.

Currently, self-management programs for patients with an ostomy mainly focus on the passive problem-solving model led by nurses and less emphasize has been placed on the self-assessment of patients who passively accept relevant knowledge and skills. This is insufficient for the pertinence, continuity, operability, and promotion of self-management. It is essential to call for a patient-tailored and theoretical approach to improve self-management and promote rehabilitation.

The transtheoretical model (TTM) is an empirically validated model of individual behavioral change, which involves progress through a series of stages to make a particular behavioral change. TTM-based interventions have been applied to facilitate health behavioral changes, such as physical exercise, smoking cessation, and weight management, studies of which continue to demonstrate positive effects. There have been few studies of patients with an ostomy using TTM as an interventional tool to provide continuous and dynamic education. Therefore, this study decided to investigate the use of an integrated method of incorporating TTM into patient instruction and to provide assistance to enhance the self-management ability of patients with an ostomy.

The aim of this study was to determine the effects of a transtheoretical model (TTM)-based intervention on ostomy self-management on patients' stages of change, processes of change, decisional balance, and self-efficacy. The study's hypotheses were: (1) There would be no significant difference between the intervention group and the control group before the intervention, and after intervention there would be more patients in the intervention group than those in the control groups. (2) Patients in the intervention group would achieve greater improvement in the ability of self-management than those in the control group.

This study was a randomized controlled trial according to the CONSORT guidelines. The sample comprised 55 men and 37 women (24 to 77 years old, mean ± standard deviation = 52.8 ± 11.13 years). The study settings included three tertiary hospitals in Changsha, Hunan, China. The 92 patients recruited were randomized into a control group and an intervention group. Instruments, including self-management behaviors, were assessed at the baseline, 2 days before discharge and after 1-, 3- and 6-month follow-up. The chi-squared test, independent sample t test, and repeated-measures analysis of variance were used to analyze the data.

Conditions

  • Self-management
  • Self Efficacy

Interventions

BEHAVIORAL

Transtheoretical Model (TTM)-based Intervention

Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one ET nurse. Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.

Sponsors & Collaborators

  • Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2012-09-30
Completion
2013-03-31

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Read the full study record

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View NCT03681821 on ClinicalTrials.gov