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1. Usage characteristics and adverse event rates ​of the direct puncture and pull techniques for percutaneous endoscopic gastrostomy in patients with malignant tumors of the upper aerodigestive tract

Author

Niels Teich, Lars Selig, Susanne Liese, Franziska Schiefke, Alexander Hemprich, Joachim Mössner, and Ingolf Schiefke

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background and study aims Patients with malignant tumors of the upper gastrointestinal tract are at risk of weight loss. Early supportive nutrition therapy is therefore recommended and usually requires placement of a percutaneous endoscopic gastrostomy (PEG). The aim of this study was to compare adverse events and usage characteristics of the direct puncture technique with those of the traditional pull technique when used in patients with endoscopically passable tumors. The primary endpoint was the rate of inflammatory adverse events (AEs) at the gastrostomy fistula. The secondary endpoint was the long-term rate of puncture-site metastases. Patients and methods One hundred twenty patients (median age 56; IQR 36, 86 years) were randomized and treated per protocol in this prospective open randomized single-center study. Follow-ups were conducted on the third and seventh post-interventional days, after 1, 3 and 6 months and the last follow-up 5 years after intervention. Results Within the short-term follow-up period of 6 months after PEG placement, AEs were noted in 47 patients (39.2 %). These included 22 inflammations and 16 device dislocations and were mainly found in the puncture group (33 vs. 14 in the pull group) with a significantly increased incidence in the first month after PEG insertion (P = 0.001). Evaluation of the 5-year data did not reveal any significant differences. The gastrostomy tube was used in 101 patients (84.2 %) (range 18 days to 5 years). Conclusions Our results favor the pull technique for patients with endoscopically passable tumors of the upper gastrointestinal tract due to less short-term adverse events. Both systems contributed equally to secure long-term use.

Published
2018
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2. Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial

Author

Kirsten Papsdorf, Franziska Schiefke, Hubert Wirtz, Anette Kersting, Jens Einenkel, Jens-Uwe Stolzenburg, Arne Dietrich, Jürgen Meixensberger, Florian Lordick, Joachim Mössner, Susanne Briest, Helge Danker, Dietger Niederwieser, Torsten Prietzel, Susanne Singer, and Andreas Dietz

Subjects
Mental Health Services, Health Knowledge, Attitudes, Practice, medicine.medical_specialty, Time Factors, Attitude of Health Personnel, Cluster randomized trial, Medicine (miscellaneous), Psycho-oncology, law.invention, Study Protocol, Quality of life (healthcare), Clinical Protocols, Randomized controlled trial, Predictive Value of Tests, law, Germany, Neoplasms, Physicians, Surveys and Questionnaires, Health care, Humans, Medicine, Pharmacology (medical), Cluster randomised controlled trial, Patient participation, Referral and Consultation, Psychiatric Status Rating Scales, Academic Medical Centers, Physician-Patient Relations, business.industry, Communication, Healthcare, Prognosis, Mental health, Distress, Mental Health, Oncology, Research Design, Family medicine, Quality of Life, Screening, Patient Participation, business, Psychosocial, Stress, Psychological, RCT
Abstract

High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine, resulting in severe undertreatment of mental health problems in this patient group. Screening tools can be used to increase case identification, however, screening alone does not necessarily translate into better mental health for the patient. Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals. This study investigates whether a stepped care model, combining screening, doctor consultation and professional psycho-oncological service in a structured way, improves the emotional wellbeing of cancer patients. This study is a cluster randomized trial with two parallel groups (intervention vs. care as usual), set in an academic hospital. Participants are cancer patients, a total of 1,000 at baseline. The intervention consists of stepped psychosocial care. Step one: screening for distress, step two: feedback of screening results to the doctor in charge of the patient and consultation with the patient, and step three: based on a shared patient-doctor decision, either transferal to the consultation liaison (CL) service or not. The outcome will be emotional well-being half a year after baseline, ascertained with the Hospital Anxiety and Depression Scale. Randomization will be done by the cluster randomization of wards. Mental health problems not only cause emotional suffering but also direct and indirect costs. This calls for timely and adequate psychosocial support, especially as we know that such support is effective. However, not every cancer patient can and must be treated by a mental health professional. Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible. It is the hope of the STEPPED CARE trial that this model is both effective and efficient, and that it can be implemented in other hospitals as well, if proven to be effective. Clinical Trials Register (Clinicaltrials.gov) identifier: NCT01859429 registration date 17 May 2013.

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