A randomised controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma
Not Applicable
Completed
- Conditions
- Colorectal cancerCancer
- Registration Number
- ISRCTN41915584
- Lead Sponsor
- Singapore Cancer Society (Singapore)
- Brief Summary
2019 qualitative results in https://pubmed.ncbi.nlm.nih.gov/30109721/ (added 17/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
1. Aged over 21 years
2. Undergoing elective colorectal resections, including both laparoscopic and open procedures that require formation of a permanent stoma
3. Able to read and speak English or Mandarin
Exclusion Criteria
1. Undergoing emergency operations
2. Having visual and/or hearing impairments
3. Having cognitive impairments/mental disorders identified in their medical records
4. Having any surgical complication leading to a delay of more than five days before attaining stoma proficiency in the post-operative period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The primary outcome measures is patients' stoma care self-efficacy. The instrument used to measure this outcome is described below:<br> The Stoma Self-Efficacy Scale consists of 22 items (Cronbach?s Alpha = 0.94), with five responses, ranging from ?not at all confident? to ?extremely confident?. Higher scores reflect positive self-efficacy. The Chinese version of the Stoma Self-Efficacy Scale will be used for patients who only understand and read Mandarin. This will be measured at four time points: baseline, mid-intervention (on the day of discharge, after the individual face-to-face session and first pre-operative telephone session), post-intervention 1 and post-intervention 2.<br>
- Secondary Outcome Measures
Name Time Method