Received a regular learning plus 3D printing model

Slide-based presention plus 3D printed port-A catheter model

3D printed educational model

Ke-Yun Chao, PhD

The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills.

Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. Proper care and maintenance are crucial for the successful use of Port-A catheters. For nursing staff, acquiring professional knowledge in Port-A catheter care is essential for improving the quality of cancer patient care. Insufficient education and training in Port-A catheter care can lead to clinical errors that endanger patients' lives.

Methods： This study involves providing training to participants and assessing their performance and effectiveness. It employs a prospective quasi-experimental design with a single group and pre- and post-test evaluations. The study includes 50 newly recruited nursing staff.

Effect： We anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in the training of newly recruited nursing staff.

3D Port-A Catheter Model for New Staff

Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff

score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.

Fu Jen Catholic University

Group leader of Respiratory Therapists

Digestive System Diseases

All Conditions

Neoplasms

Colonic Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Laxatives

Cathartics

The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.

The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet.

Laxative 4 liters polyethylene glycol 4000 in split fashion.

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

Low-residue diet

Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Usual care

Marco Antonio Alvarez González, MD, PhD

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.

All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study

The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation

Ratio of successful cecal intubations in each study arm

Ratio of polyps and adenomas detected in each study arm

Each participant will rate his/her experience in an analogue visual scale

Description of all spontaneously reported adverse events.

Each participant will rate his/her experience in a questionnaire.

Parc de Salut Mar

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Dexamethasone

Lenalidomide

Daratumumab

Dexamethasone acetate

Patients either continue DRd with daratumumab iv, switch to daratumumab sc or switch multiple times iv/sc

Patients either continue DRd with daratumumab sc, switch to daratumumab iv or switch multiple times sc/iv

Wolfgang Knauf, Prof. Dr.

MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label.

250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.

Therapy options for MM are mainly dependent on the age and fitness of the patients. NDMM patients up to the age of 65-70 years in whom autologous stem cell transplantation is not indicated, anti-myeloma treatment traditionally consists of systemic chemotherapy, with adjunctive use of radiation or surgery in selected cases associated with extramedullary disease. However, the therapeutic landscape of multiple myeloma progressed in the past decade with the introduction of immunomodulatory agents, proteasome inhibitors and anti-CD38 antibodies, like Daratumumab.

After approval of daratumumab iv in May 2016, the sc daratumumab application route was approved in June 2020 in Germany. Real-world evidence data, however, are not yet available neither related to daily experience nor to satisfaction with daratumumab sc application nor to the proportion of patients potentially switching from daratumumab iv to sc application.

MYLENE aims to close these gaps with focus on NDMM patients who are ineligible for autologous stem cell transplantation and who will be treated with DRd; this is to guarantee a homogenous patient population.

All aspects of treatment and clinical management of patients will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the healthcare provider (or treating physician where different). Only data available per clinical practice will be collected within this study. Additionally, where permitted in accordance with local regulations, healthcare providers will be asked to obtain patient-reported outcome (PRO) data from patients within this study. Despite use of PROs and HCP as well as physician questionnaires, the design is non-interventional due to the fact that the questionnaires are structured documentation aids to document questions that are routinely part of the dialog between patient and physician or HCP during the patient visit and/or drug administration or that are considered by the HCP when evaluate treatment for the patient but are not documented in the medical record.

MYLENE is unique as it is focusing on the satisfaction of all involved stakeholders (i.e., patients and HCPs) under real-word conditions and mainly in private practices, since this patient collective is treated preferentially in these institutions, allowing to receive direct feedback about the use of daratumumab sc application and its potential hurdles or/and limitations. Furthermore, this study will provide insights on how the sc/iv application is managed in clinical routine as well as how it is perceived by medical professionals over time.

This NIS will be analyzed exploratively and is hence not designed to confirm or refute a predefined hypothesis.

Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)

Prospective, Multicenter, Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients as Per Routine Clinical Practice in Germany Depending on Application Route (sc or iv)

Occurence and number of patients with (treatment-related) adverse events will be provided.

Additionally, summary tables of selected subsets of AEs will be displayed summarized by system organ class (SOC) and preferred term (PT), sorted by frequency of SOC and PT. Summary tables for AEs will include only AEs that started or worsened during the on-treatment period. However, safety data from the pre- and post-treatment periods will be listed separately.

Time to first occurrence of AESI will be calculated for patient with an AESI as the time from the date of first application of daratumumab until onset of first documented AESI and will displayed with descriptive statistics.

The primary objective of this NIS is to exploratively analyze patients' satisfaction of sc and iv application of daratumumab over time as measured by the "Patient Satisfaction and Time Questionnaire" (PatSTQ).

Overall patients´ satisfaction with daratumumab administration will be displayed as the result of one defined question in the PatSTQ, with descriptive statistics and boxplots.

Results of PatSTQ will be displayed with frequencies per group and by time point. Additionally, stacked bar plots with questionnaire results (including missings) per item and time point will be presented

The secondary objective of this NIS is to assess HCPs' satisfaction of sc and iv application over time as measured by the "HCP Satisfaction and Time Questionnaire - patient specific" (HSTQ-ps).

HCPs' application route satisfaction will be displayed by questionnaire time point as result of the HSTQ - ps questionnaire with frequencies for questions and with descriptive statistics.

The proportion of HCP active time spent on activities (drug preparation, drug administration, patient care/patient monitoring) over time

Patients' overall time spent at doctor's office

The switch rate (proportion of patients) of daratumumab application routes during 12 months of study participation under real-word conditions

The main reasons for sc or iv application selection evaluated by both, the "Physician Therapy Decision Questionnaire - general" (PTDQ-g) at study start and at the end of study (i.e., study close-out) and by the "Physician Therapy Decision Questionnaire - patient specific" (PTDQ-ps) at baseline and at switch of the application route

The impact of different factors on therapy decision and application route selection will be displayed as parameter estimates for selected fixed covariates (age, cytogenetics (high vs standard) and relevant comorbidities) in a mixed effects logistic regression model with the result of PTDQ-ps as outcome.

The treating physician selects up to two main reasons why the (new) application route (sc or iv) of daratumumab for a patient is chosen.

Patients' preference of the application route (only for patients switching from one application route to another) as measured by the "Patient Preference Questionnaire" (PatPQ).

The patient selects which method of daratumumab administration (iv or sc) is preferred and up to two reasons for the preference.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3D Port-A Catheter Model for New Staff	NCT06416943	Personal Satisf... Cancer	3D printed educ...	18 Years - 30 Years	Fu Jen Catholic University
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy	NCT02401802	Colonic Disease...	Low-residue die... Usual care	18 Years -	Parc de Salut Mar
3D Port-A Catheter Model for New Staff	NCT06416943	Personal Satisf... Cancer	3D printed educ...	18 Years - 30 Years	Fu Jen Catholic University
Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)	NCT05284591	Multiple Myelom... Newly Diagnosed Transplant Inel... Patient Satisfa... Patient Prefere... Personal Satisf...	Daratumumab	18 Years -	iOMEDICO AG

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