Neoplasms

Digestive System Diseases

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Colorectal Neoplasms

Pneumonia, Pneumocystis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pneumocystis Jirovecii Pneumonia

Pneumocystosis

Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.

Physician's counseling

Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.

Information leaflet

Jaroslaw Regula, MD, PhD

Michal F. Kaminski, MD, PhD

Michal Wiszniewski, MD

The purpose of this study is to assess the impact of physician's counseling on participation and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening program

Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.

To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.

In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.

The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program

The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program

Centre of Postgraduate Medical Education

Maria Sklodowska-Curie National Research Institute of Oncology

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Folfirinox

Inclusion criteria:

1. Age ≥18 years;
2. Pathology confirmed LAPC\*;
3. CT-based non-progressive disease in accordance with the RECIST criteria after at least 4 months of systemic chemotherapy (\[m\]FOLFIRINOX or gemcitabine-nab-paclitaxel).

Exclusion criteria:

(1) Metastatic pancreatic cancer prior to induction chemotherapy.

\*According to the Dutch Pancreatic Cancer Group (DPCG) definition: \>90 degrees arterial tumor involvement (i.e. superior mesenteric artery, celiac axis, and/or hepatic artery) and/or portovenous involvement of either \>270 degrees or occlusion.

The PREOPANC-4 project aims to safely implement the international standard of excellence for LAPC management and surgery using a multidisciplinary best-practice training program, based on the experiences of four leading international expert centers (i.e. NYU Langone Health, University of Colorado, Heidelberg University, and MD Anderson Cancer Center). We hypothesize that the PREOPANC-4 implementation project will result in the improvement in multidisciplinary patient management and selection in line with current international best-practice.

Implementation - International best-practice care

Thomas F Stoop, MD

Marc G Besselink, MD, MSc, PhD

Marc G Besselink, MD, PhD, MSc

A prospective, nationwide, implementation program of the international standard of excellence for locally advanced pancreatic cancer (LAPC) care in the Netherlands (2021\[7\]-2030\[6\]), including a multidisciplinary training program by the four leading international expert centers.

The PREOPANC-4 project aims a safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.

Rationale:

Non-metastasized locally advanced pancreatic cancer (LAPC) is diagnosed in 35% of all pancreatic cancer patients and is traditionally treated with palliative care. Recently, the multidisciplinary management of LAPC has evolved by the introduction of modern multi-agent induction chemotherapies, leading to an increased resection rate and improved outlook for five-year survival. In contrast, five-year survival after chemotherapy without surgery is virtually non-existent. In the Netherlands, the LAPC resection rate after induction chemotherapy remains low with 8% versus 25% in international centers of excellence, leading to missed opportunities for five-year survival in a selected subgroup of LAPC patients. Explanations for this large difference include the spectrum of chemotherapy use, interpretation of diagnostics, patient selection, and surgical techniques.

Objective:

A safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.

Study design:

A prospective, nationwide, implementation program of the international standard of excellence for LAPC care in the Netherlands (2021\[7\]-2030\[6\]), including a multidisciplinary training program by the four leading international expert centers (i.e. University of Heidelberg, University of Colorado, NYU Langone, and MD Anderson Cancer Center). Subsequently, the three Dutch centers with the highest surgical volume and documented experience in LAPC surgery will implement this highly complex LAPC surgery in close collaboration with the other Dutch Pancreatic Cancer Group (DPCG) centers. Patients who meet the inclusion criteria will be discussed within an online (inter)national expert panel to properly select patient for surgery. In addition, the other DPCG centers can present their LAPC patients to this panel for advice about (surgical) treatment options and if these patients should be referred to the three high-volume DPCG centers for surgery. Outcomes will be compared with a historical Dutch LAPC cohort, using propensity score matching.

Study population:

Adult patients with pathology confirmed non-metastasized LAPC and non-progressive disease after at least four months of (modified) FOLFIRINOX or gemcitabine-nab-paclitaxel induction chemotherapy and fit for major surgery.

Study aim:

The primary study aim is to double the LAPC resection rate in the Netherlands from 8% to 16% with adequate survival and morbidity targets.

Primary targets:

1. Survival: After resection, mOS of 25 months, 1-year survival \>90%, and 5-year survival \>20%. These outcomes will be compared to the Dutch cohort of patients (2015-2020) with RECIST non-progressive LAPC after induction chemotherapy who did not undergo surgical exploration;
2. In-hospital morbidity and mortality: in-hospital/30-day mortality ≤5% and in-hospital major morbidity of \<50% after resection, which will be compared with a recent Dutch cohort (2015-2020) of resected patients with borderline resectable and locally advanced pancreatic cancer after induction/neoadjuvant therapy.

Secondary targets:

1. Non-inferior radical resection (R0) rate as compared to a recent Dutch cohort (2015-2020) of resected patients with borderline resectable and locally advanced pancreatic cancer after induction/neoadjuvant therapy;
2. Non-inferior quality of life, mental and physical health status, and potential side effects on the long-term follow-up, compared to a control cohort of Dutch LAPC patients;
3. Non-inferior patients' healthcare satisfaction, compared to the Dutch historical cohort of pancreatic cancer patients.

PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer

Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)

OS from time of resection (mOS, 1-year OS \& 5-year OS)

Mortality after resection (during primary hospitalization)

Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)

R0 (microscopic radical resection \>1mm) versus R1 (microscopic residual tumor ≤1mm). NB. For the anterior margin, only direct ingrowth is considered as R1.

EORTC QLQ-C30: global health status

Outcome measures will be calculated, according to the validated questionnaire manuals.

APECC decision-making self-efficacy scale.

Outcome measures will be calculated, according to the validated questionnaire manuals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program	NCT01688817	Colorectal Neop...	Physician's cou... Information lea...	50 Years - 65 Years	Maria Sklodowska-Curie National Research Institute of Oncology
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer	NCT05524090	Pancreatic Canc... Locally Advance... Pancreatic Aden... Chemotherapy Ef...	Implementation ...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer	NCT05524090	Pancreatic Canc... Locally Advance... Pancreatic Aden... Chemotherapy Ef...	Implementation ...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for patient selection