Development of a Patient Decision Aid for Rectal Cancer Patients with Clinical Complete Response after Neo-Adjuvant Treatment.

Surgery is the primary component of curative treatment for patients with rectal cancer. However, patients with a clinical complete response (cCR) after neo-adjuvant treatment may avoid the morbidity and mortality of radical surgery. An organ-sparing strategy could be an oncological equivalent alternative. Therefore, shared decision making between the patient and the healthcare professional (HCP) should take place. This can be facilitated by a patient decision aid (PtDA). In this study, we developed a PtDA based on a literature review and the key elements of the Ottawa Decision Support Framework. Additionally, a qualitative study was performed to review and evaluate the PtDA by both HCPs and former rectal cancer patients by a Delphi procedure and semi-structured interviews, respectively. A strong consensus was reached after the first round (I-CVI 0.85-1). Eleven patients were interviewed and most of them indicated that using a PtDA in clinical practice would be of added value in the decision making. Patients indicated that their decisional needs are centered on the impact of side effects on their quality of life and the outcome of the different options. The PtDA was modified taking into account the remarks of patients and HCPs and a second Delphi round was held. The second round again showed a strong consensus (I-CVI 0.87-1).

Illness Identity in Inflammatory Bowel Disease.

BACKGROUND: We examined the degree to which adults with inflammatory bowel disease (IBD) integrated their illness into their identity and linked illness identity to important patient-reported outcomes. METHODS: A total of 109 adults with IBD, aged 18 to 60 (Mage = 35.93; 77% women) completed questionnaires on the four illness identity dimensions (rejection, acceptance, engulfment, and enrichment), medication adherence, depressive symptoms, life satisfaction, health status, and health-related quality of life (HRQoL). The illness identity scores of adults with IBD were compared to existing data from adults with congenital heart disease (CHD), refractory epilepsy (RE), and multisystemic connective tissue disorders (MSDs) using multivariate analyses of covariance. In adults with IBD, associations between illness identity and patient-reported outcomes were examined through hierarchical regression analyses, controlling for sex, age, illness duration, diagnosis, self-reported flares, and co-existing illnesses. RESULTS: Adults with IBD scored higher on rejection and engulfment and lower on acceptance than adults with CHD, lower on rejection but higher on engulfment than adults with RE, and higher on engulfment and enrichment but lower on rejection than adults with MSDs. Higher engulfment scores were related to more depressive symptoms, lower life satisfaction, and a poorer health status and HRQoL. In contrast, higher enrichment scores were related to more life satisfaction and a better HRQoL. Rejection and acceptance were not uniquely related to any of the outcomes. CONCLUSIONS: Adults with IBD showed relatively high levels of engulfment. Substantial associations were observed between illness identity and patient-reported outcomes, with engulfment being the strongest, most consistent predictor.

Nonoperative versus operative approach according to the response to neoadjuvant chemoradiotherapy for rectal cancer: A prospective cohort study.

Purpose: To report on organ preservation following chemoradiotherapy (CRT) in a prospective cohort of locally advanced rectal cancer patients. Methods and materials: Fifty-two patients received CRT. MRI and 18F-FDG-PET/CT were performed prior to CRT. Response assessment was done 6 and 12 weeks after CRT using digital rectal examination, MRI, 18F-FDG-PET/CT and endoscopy. For clinical complete response or minimal residual disease, a watch-and-wait (W&W) protocol was started.Regrowth-free survival (ReFS), Total Mesorectal Excision-free disease-free survival, distant metastasis-free survival (DMFS) and overall survival (OS) were evaluated using Kaplan-Meier method. Functional outcome was compared with the Wilcoxon signed-rank test using EORTC QLQ-C30, MSKCC BFI, LARS and IIEF-5/FSFI-5 questionnaires. A previously developed prediction model performance was tested using receiver operating characteristic analysis. Results: 29/52 patients entered a W&W protocol. There was no difference in two-year DMFS (81.1 % vs 78.8 %, p = 0.82), two-year OS (96.4 % vs 100 %, p = 0.38) and two-year DFS (77.5 % vs 78.8 %, p = 0.87) between W&W patients and those who underwent surgery at 12 weeks after CRT. Two-year DMFS differed between W&W with local regrowth, W&W with sustained response and patients who had surgery (66.7 % vs 88.0 % vs 78.8 %; p = 0.04). At 6 and 12 months, W&W patients reported good QoL and bowel function. The model validation reached an AUC of 0.627. Conclusion: Good functional outcome in patients with rectal cancer allocated to surveillance after CRT needs to be balanced against potentially worse DMFS in a subset of patients without sustained clinical complete response. Reliable prediction of patients eligible for surveillance programs needs further investigation.

Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

INTRODUCTION: Radical surgery after a total mesorectal excision (TME) for rectal cancer often results in a significant decrease in the patient's quality of life, due to functional problems such as bowel, urinary and sexual dysfunction. The effect of pelvic floor muscle training (PFMT) on these symptoms has been scarcely investigated. We hypothesise that the proportion of successful patients will be significantly higher in the intervention group, receiving 12 weeks of PFMT, compared with the control group without treatment. The primary outcome of this trial is the severity of bowel symptoms, measured through the Low Anterior Resection Syndrome questionnaire, 4 months after TME or stoma closure. Secondary outcomes are related to other bowel and urinary symptoms, sexual function, physical activity and quality of life. METHODS AND ANALYSIS: This research protocol describes a multicentre single blind prospective, randomised controlled trial. Since January 2017, patients treated for rectal cancer (n=120) are recruited after TME in three Belgian centres. One month following surgery or, in case of a temporary ileostomy, 1 month after stoma closure, patients are randomly assigned to the intervention group (n=60) or to the control group (n=60). The assessments concern the preoperative period and 1, 4, 6, 12 and 24 months postoperatively. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki. Ethics approval was granted by the local Ethical Committee of the University Hospitals Leuven (s59761) and positive advice from the others centres has been obtained. Dissemination of the results will be accomplished via guidelines and (non-)scientific literature for professionals as well as organisation of patient symposia. TRIAL REGISTRATION NUMBER: NTR6383.