The FOCCUS study: a prospective evaluation of the frequency, severity and treatable causes of gastrointestinal symptoms during and after chemotherapy.

BACKGROUND: The underlying mechanisms of chemotherapy-induced gastrointestinal (GI) symptoms are poorly researched. This study characterised the nature, frequency, severity and treatable causes for GI symptoms prospectively in patients undergoing chemotherapy for GI malignancy. METHODS: Patients receiving chemotherapy for a GI malignancy were assessed pre-chemotherapy, then monthly for 1 year using the Gastrointestinal Symptom Rating Scale, a validated patient-reported outcome measure. Patients with new, troublesome GI symptoms were offered investigations to diagnose the cause(s). Their oncologist was alerted when investigations were abnormal. RESULTS: A total of 241 patients, 60% male, median age 63 years (range 30-88), were enrolled; 122 patients were withdrawn, 93%, because of progressive disease or death. During the study, > 20% patients reported chronic faecal incontinence and > 10% reported moderate or severe problems with taste, dysphagia, belching, heartburn, early satiety, appetite, nausea, abdominal cramps, peri-rectal pain, rectal flatulence, borborygmi, urgency of defecation or tenesmus. Thirty percent reported continuing passage of hard stools and 30% on-going diarrhoea. Moderate or severe fatigue affected 40% participants at its peak and persisted in 15% at 1 year. Toxicity dictated change in chemotherapy for 13-29% patients/month. Common Terminology Criteria for Adverse Events underestimated gastrointestinal morbidity. Pre-chemotherapy screening identified previously undiagnosed pathology: exocrine pancreatic insufficiency (9%), vitamin B12 deficiency (12%) and thyroid dysfunction (20%). Patients often refused investigations to diagnose their chemotherapy-induced symptoms; however, for every three investigations performed, one treatable cause was diagnosed: particularly small intestinal bacterial overgrowth (54%), bile acid malabsorption (43%), previously not described after chemotherapy, and unsuspected urinary tract infection (17%). CONCLUSIONS: Patients undergoing chemotherapy for GI malignancy commonly have difficult GI symptoms requiring active management which does not occur routinely. The underlying causes for these symptoms are often treatable or curable. Randomised trials are urgently needed to show whether timely investigation and treatment of symptoms improve quality of life and survival. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02121626.

Reflective practice applied in a clinical oncology research setting.

Regular reflective practice group sessions, focusing on enhancing mindfulness, were piloted as part of a support programme for researchers in a clinical oncology setting. METHODS: As a previous systematic review highlighted a wide variety of approaches and a lack of published evidence on the use of specific models for reflective practice in health care, a scoping review of existing literature describing reflective practice models preceded piloting the programme with the research team. The Mindful Attention Awareness Scale (MAAS) was used to assess the benefit for participants. Scores from the first and last session were analysed using a paired-sample t-test. Feedback from questionnaires was analysed using descriptive statistics (for Likert scales) and direct quotes from free text exemplified the experience. RESULTS: Seven people participated. Six were female, all were research nurses except for one research allied health professional. The median age was 37 (range: 23-40 years). The average time since graduation was 10 years (range: 1.5-18 years). All researchers worked in a tertiary oncology setting. Although a total of 21 reflective practice sessions were facilitated, the median number of sessions attended was 9 (range: 2-21). The mean MAAS score improved from 57.83 to 62.83 (p=0.0146). The participants rated the experience and impact as positive. CONCLUSION: The results of the MAAS score indicate that mindfulness was enhanced by the sessions. The feedback from the participants highlighted the impact on their professional development. This is encouraging to support developing similar facilitated reflective practice programmes in different settings.