O’Connor, G., Coates, V., & O’Neill, S. (2014). Randomised controlled trial of a tailored information pack for patients undergoing surgery and treatment for rectal cancer. European Journal of Oncology Nursing, 18, 183–191. 

To evaluate the effects of a tailored information package for patients with rectal cancer on levels of satisfaction with information, anxiety, depression, and readjustment to normal living

This study was conducted at six sites in four healthcare systems in Northern Ireland. A process evaluation of usual standards-of-care established that all patients with rectal cancer were referred to a stoma nurse specialist following diagnosis. A tailored information packet of 14 leaflets dealing with various aspects of disease and treatment was developed based on the theoretical framework of andragogy, developed by Malcolm Knowles, along with a preliminary needs assessment and a literature review. Preparation for the study involved a liaison between stoma-care nurse specialists to determine interest in participation. The researchers then met with the stoma nurse specialists to discuss the study protocol and provide consistent training regarding the use of the information packet. Data were collected using a researcher-administered set of scales at three time points in structured interviews. These were preintervention, postintervention, after surgery, prior to hospital discharge, and six months after surgery.

• N = 43 (intervention group), 33 (control group)  
• AGE RANGE = 42–76+ years
• MALES: 64.5%, FEMALES: 35.5%
• KEY DISEASE CHARACTERISTICS: Sixty-eight out of 76 patients were considered a B or C in Duke’s staging system. The majority of patients (40) had low anterior resections with loop ileostomies, and 27 patients had abdominoperineal resections (permanent colostomies).
• OTHER KEY SAMPLE CHARACTERISTICS: Thirty-two patients received short-course radiation prior to surgery. Ten of these patients also had adjuvant chemotherapy. Nine patients had long-course preoperative chemotherapy/radiation, and nine patients had adjuvant chemotherapy only.

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Northern Ireland

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care 

Randomized, controlled trial

The Patient Satisfaction with Cancer Treatment Education (PSCaTE) questionnaire was used. It consists of 14 items. Each item has a scale from 1 (strongly disagree) to 5 (strongly agree). The Hospital Anxiety and Depression Scale (HADS), which contains seven intermingled items answered on a four-point scale, and the Reintegration to Normal Living Index (RNLI), which consists of 11 items on scales of 1–10, also were used. Data analysis was carried out using SPSS software.

There was a statistically significant difference in levels of satisfaction with information between the intervention and control groups. Patients who received the tailored information packet were more satisfied with their information than the control group. There were no differences in depression scores between the intervention and control groups at any time. Females were shown to have significantly higher anxiety and depression scores at the preintervention assessment. All participants with high depression scores also had elevated anxiety scores. Anxiety and depression scores showed medium to large negative associations with adjustment levels as measured by the RNLI scores at all three time points.

Patients who received the tailored information packets were significantly more satisfied than those in the control group at the second and third time points.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: This study only assessed satisfaction up to six months following surgery. Caregivers were not included in the study. This study focused predominantly on paper-based literature as an intervention. The Pearson coefficient was used in the analysis to assess for satisfaction; although this is appropriate, it is not as robust in terms of statistical significance.