A randomised controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma

The primary outcome measures is patients' stoma care self-efficacy. The instrument used to measure this outcome is described below:
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.

The secondary outcome measures are days to stoma proficiency, length of hospital stay, acceptance of stoma, level of anxiety and depression and quality of life. The instruments used to measure these secondary outcomes are described below:
1. The days to stoma proficiency is defined as the number of days from date of surgery to achievement of proficiency as assessed with the protocol of standard stoma education. This protocol checklist is developed for the purpose of this study.
2. Medical record review will be used to collect data of the length of post-operative hospital stay, which is defined as the number of days from the date of surgery to the date which the patient is deemed fit for discharge by the surgical team in charge.
3. The Acceptance of Chronic Health Conditions Scale (ACHC scale) is used as the measure of acceptance. This scale measures acceptance of chronic health conditions in general. In order to enable participants to focus on their stoma, the phrase ‘chronic health conditions’ was replaced by the word ‘stoma’ with the advice from the author. The ACHC scale consists of 10 items, each measured on a 5-point Likert scale (1 = strongly agree, 5 = strongly disagree). Thus, higher scores indicate higher levels of acceptance. The Chinese version of the scale will be used for patients who can only understand and read Mandarin.
4. Patients’ level of anxiety and depression will be assessed using the Hospital Anxiety Depression Scale (HADS). It is divided into two main sections with one section focusing on anxiety, which is marked ‘A’, while the other focusing on depression, which is marked ‘D’. Patients are advised to provide an immediate and spontaneous response. Each statement has four responses graded from 0-3. There will be a maximum possible score of 21 for both anxiety and depression. In order to make it a more effective and detailed tool, the scores can been further analysed: a patient scoring 11 or more on either component will be considered at risk of anxiety or depression; a patient scoring 8–10 will be considered at borderline risk of anxiety or depression. Meanwhile, patients scoring 0–7 will be within the normal range. The Chinese version of the HADS will be used for patients who can only understand and read Mandarin.
5. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal 29-item questionnaire (EORTC QLQ-CR29) will be used to measure the quality of life in patients with stoma. The QLQ-CR29 served to collect information on patients’ disease-specific symptoms and adverse effects. The module is divided into four main functions assessing urinary frequency, faecal seepage, stool consistency and body image, and single items assessing other common problems following treatment for colorectal cancer. There are 18 items which address gastrointestinal symptoms, pain and problems with micturition. There are separate scales and issues with micturition. There are separate scales for participants without a stoma, which are not relevant to this study and hence not mentioned. There are also separate items which address sexual function for men and women. The responses to the QLQ-CR29 were linearly converted into 0–100 scores using standard EORTC guidelines. A high score indicates worse symptoms. The Chinese version of the questionnaire will be used for patients who can only understand and read Mandarin.