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

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN41915584
• Date of registration: 25/07/2014
• Prospective Registration: Yes
• Primary sponsor: Singapore Cancer Society (Singapore)
• Public title: A randomised controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma
• Scientific title: A randomised controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol
• Date of first enrolment: 01/01/2015
• Target sample size: 84
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN41915584
• Study type: Interventional
• Study design: Randomized controlled two-group pretest and repeated posttests single-blind experimental design (Treatment)
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Hong-Gu He

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal cancer
Cancer

Intervention(s)

There are two groups in the study.
1. Control: The participants in the control group will only receive routine care provided by the hospital.
2. Intervention: The participants in the intervention group will receive routine care and STOMA psychosocial intervention. The STOMA psychosocial intervention programme includes an individual psychoeducation face-to-face session (pre-operatively) with booklet provided, and five telephone follow-up sessions (one pre-operatively and four post-operatively). The main contents include:
2.1. An introduction to psychosocial interventions
2.2. An outline of the STOMA psychosocial intervention programme which focuses on encouraging open communication, identifying family resources, encouraging a positive attitude, promoting acceptance, effective and healthy coping with continuity of lifestyle behaviours, handling overwhelming stress, sharing fears and negative feelings, reducing and adapting to uncertainty, assessment of needs, and empowering with self-care strategies
2.3. Availability of community resources and support services
2.4. Common issues and concerns in resuming activities post-operatively with a stoma
2.5. A step-by-step guide in stoma care training
2.6. Stoma education protocol to guide participants in setting goals

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

JAN-2014-0582

Source(s) of Monetary Support

Singapore Cancer Society (Singapore)

Ethics review

Status:
Approval date:
Contact:

SingHealth Centralized Institutional Review Board (CIRB), 24/10/2013, ref. 2012/1038/A

Results

• Results available: Yes
• Date Completed: 30/06/2017