Patients will receive current standard care of EHR-integrated symptom monitoring.

Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention.

Enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. After patients complete the current EHR-integrated symptom monitoring, they will receive web-based, patient-centered information to gain knowledge on cancer-related outcomes, improve self-management skills, improve communication skills, and empower them to improve motivation and self-management.

Patient Self-management

David Cella, PhD

Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Our research center, Northwestern University IMPACT (NU IMPACT), builds upon an electronic health record (EHR)-integrated cancer symptom monitoring and management system, currently deployed by our health care system. We are testing the effectiveness of a system-wide symptom management intervention and the EHR-integrated enhanced care approach, which offers a more personalized symptom monitoring and management experience based on a person's unique needs and language (i.e., English or Spanish).

Using a clinic-level randomized roll-out implementation trial design, we will test the effectiveness of an enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. The existing EHR-integrated symptom monitoring system will constitute usual care (UC), and added patient engagement and activation features will comprise the EC condition.

Project aims target both patient- and system-level outcomes. Aim 1: Implement a fully-integrated oncology symptom assessment and management program across six clinical units that are part of the NMHC healthcare delivery system; Aim 2: Evaluate the impact of the program by conducting a hybrid Type I effectiveness-implementation trial to evaluate the enhanced care program (EC: symptom monitoring \& self-management intervention), relative to usual care (UC) on patient- and system-level outcomes; Aim 3: Identify facilitators and barriers to implementation and disseminate to other health systems. We will enroll an estimated 12,671 participants. To address possible contamination effects within each clinical unit, and allow for unit-level data collection for pre- and post-implementation comparison within and across clinical units, 50% will be enrolled and followed prior to program implementation. The other half will be enrolled post-implementation and will be randomly assigned at a 1:1 ratio (stratified by sex and cancer phase; curative intent, non-curative intent \& survivorship) to UC versus EC. Fatigue, pain, anxiety, and depression will be assessed using Patient Reported Outcome Measurement Information System (PROMIS®) computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including healthcare utilization, and cancer treatment delivery outcomes.

This trial design, in conjunction with our aims and measurement strategy, is consistent with a hybrid Type I effectiveness-implementation trial, which primarily tests the clinical effectiveness of an evidence-based intervention while secondarily documenting and evaluating its implementation. The randomized roll-out implementation trial design is in the same class as the commonly-used stepped wedge trial, but is more practical for real-world application due to lower measurement burden on clinics due to using incomplete wedges. To assess implementation at the level of the clinic, and control for patient-level outcome prior to implementation, we use a pragmatic randomized roll-out implementation trial design with an embedded patient-level randomized group-based comparison.

Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center

Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center

Symptom severity will be assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) related to symptoms of pain, fatigue, depression, anxiety, and physical function. CAT question items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Patient usually completes 4-12 items with a high level of measurement precision for each domain.

Adverse symptom severity will be assessed using Patient-Reported Outcomes- Common Terminology for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask about nausea, constipation, insomnia, vomiting, shortness of breath, and diarrhea.

Participant utilization of healthcare services, such as number of emergency room visits, oncology urgent care visits, unscheduled doctor visits, doctor visits, hospital admissions and length of stay, and supportive care needs to manage their cancer and cancer treatment, will be assessed by electronic health records.

Patient satisfaction of their cancer-related care will be assessed using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey composite measures.

Cancer recurrence will be assessed by electronic health record diagnosis codes in patients in curative intent and survivorship groups.

Cancer progression will be assessed by electronic health records diagnosis codes in curative intent and non-curative intent groups.

Second cancer will be assessed by patient medical record diagnosis codes in curative intent, non-curative intent, and survivorship groups.

Overall survival will be assessed by electronic health records in the curative intent and non-curative intent groups.

Northwestern Medicine

National Cancer Institute (NCI)

Northwestern University

Professor and Chair, Department of Medical Social Sciences

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Fluorodeoxyglucose F18

Patients with non-small cell lung carcinoma treated with curative intent

Thierry Berghmans, MD

The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).

Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

European Lung Cancer Working Party

Head and Neck Neoplasms

* Patients with a primary diagnosis
* Patients treated with curative intent (stage I-IVb)

* Patients with a recurrent (loco)regional tumour
* Patients treated with curative intent (stage I-IVb)

Araceli Diez-Fraile, Phd

Araceli Diez-Fraile, PhD

Johan Abeloos, MD

Background Approximately half of head and neck cancer patients are 65 years or older at diagnosis. Treatment decisions in this older HNCA population are challenging, because of the lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting where curative treatment is intended. Though chronological age per se has not been reported as a contraindication for surgery, data are limited and often the result of retrospective studies. Measurement of functional age, through a comprehensive geriatric assessment, has been suggested by several international cancer organizations to be a better prognostic indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric assessment is part of routine preoperative staging for patients of 70 years old or older.

Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they aim to examine the vulnerability profile of patients undergoing elective head and neck surgery for an oncology diagnosis.

Study design All patients of 70 years and older, presenting at the divisions of maxillofacial surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo a geriatric consult as part of routine preoperative staging. The presence of postoperative morbidity and mortality within the first 30 days after surgery will be collected as a primary endpoint.

At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA. Patient' quality of life will also be re-examined within 30 days postoperative and again at 6 and 12 months postoperative.

Conclusion There is still no consensus whether older HNCA patients should receive a different treatment compared to younger patients. Data related to the vulnerability profile of older patients requiring HN surgery, and the predictive value of geriatric screening for postoperative morbidity could enable better patient selection in the future.

Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer

Determination of the Value of Geriatric Screening to Predict Postoperative Morbidity in an Older Head and Neck Cancer Population (GEROP)

AZ Sint-Jan AV

head of department of maxillofacial surgery, principal investigator

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

CP-870,893

Robert Vonderheide, MD, DPhil

This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893 will be pre-op and 3 doses post-op.

This is an open-label single-arm,phase 1, trial. Ten patients with newly diagnosed resectable pancreatic carcinoma will receive gemcitabine and CP-870,893 two weeks prior to surgical resection and subsequently during standard-of-care adjuvant chemoradiation therapy (at which time CP-870,893 will be given on day 3 of each of three 28-day cycles of gemcitabine). Previously established doses of each agent will be used and each given by IV infusion.

Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

Phase 1 Study of Preoperative Gemcitabine Plus CP-870,893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patient With Newly Diagnosed Resectable Pancreatic Carcinoma

Abramson Cancer Center at Penn Medicine

Carcinoma, Hepatocellular

Liver Neoplasms

Liver Diseases

Lenvatinib

Tin Fluorides

Protein Kinase Inhibitors

Enzyme Inhibitors

Neoadjuvant therapy with lenvatinib to complete a 3-week course, stopping 1 week before the planned date of PA procedure " LENVABLA " protocol, version 1.3 du 25/05/2021 12/55

- Adjuvant therapy with lenvatinib for 3 months starting after the PA evaluation (± 14 days) The daily dose of lenvatinib will be 12 mg (≥60 kg) or 8 mg (\<60 kg). Lenvatinib will be taken within 2 hours after a light meal, preferably in the morning.

The design of study is summarized as follows:

* Neoadjuvant phase with lenvatinib for 21 days (rationale: compromise between expected benefit and acceptable tolerance without compromising ablation procedure)
* PA of HCC in a curative intent (radiofrequency, microwave or electroporation)
* Adjuvant phase with lenvatinib for 3 months (rationale: compromise between expected benefit and acceptable tolerance without compromising ablation procedure)

Lenvatinib Pill

Pierre NAHON, MD-PhD

Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure. In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques which allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria. In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume than can be ablated, allowing the removal of large tumors\> 5 cm. Inadequate tumour control is then de facto greater in these situations, around 20%. Difficult-to-access tumors can furthermore be treated by percutaneous irreversible electrotroporation (IRE).

Despite a tumor burden accessible for curative ablation, a phenotype of "aggressive" HCC characterized by high rates of local recurrences is yet to be defined. Up to now, several characteristics might define this subtype with a poor-prognosis and include 1) high serum alpha-foetoprotein (AFP) levels, 2) radiological infiltrative form, and 3) histological macrotrabecular subtype. Based on these characteristics, median recurrence-free survival of these patients is usually below 10 months.

High serum AFP level is a well-known predictor of HCC recurrence following curative procedure. In patients treated by percutaneous ablation, regardless of the technique used and irrespective of tumor burden, high baseline serum AFP level has tenaciously been reported as an independent predictor or recurrence..

More recently, the radiological description of infiltrative HCC (as opposed to mass-forming) has been identified as an aggressive from of HCC with a poor prognosis even when eligible for ablation. This aspect is often associated with infra-clinical invasion of the portal veins (PV), leading to poor prognosis. Finally, a "massive macrotrabecular" (MTM) histological subtype of HCC associated with specific molecular features has recently been described. This MTM-HCC subtype, reliably observed in 12% of patients eligible for curative treatment, represents an aggressive form of HCC is an independent predictor of early and overall recurrence following PA, which is retained even after patient stratification according to common clinical, biological, and pathological features of aggressiveness.

The idea of optimizing HCC curative treatments using adjuvant biotherapy, particularly in patients with poor-prognosis tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients within Milan HCC, with an expected low rate of recurrence with only few patients treated by PA.

Lenvatinib is a multikinase inhibitor which has been recently approved as firs-line therapy for advanced HCC. The investigators assume that lenvatinib could have also a synergistic local action with PA in two ways. First, given as neoadjuvant regimen, lenvatinib by reducing tumor and liver perfusion could decrease the global heat sink effect associated with loco-regional blood microcirculation during PA. Second, by carrying on in adjuvant treatment, lenvatinib could decrease the magnitude of non-specific inflammatory angiogenesis around the treatment zone, therefore reducing the risk of locoregional (intrasegmental) cells tumor spreading or promotion.

Given the dismall prognosis of the aforementioned poor-prognosis HCC eligible for PA with an overall median recurrence-free survival below 10 months, the investigators hypothesis is that addition of Lenvatinib as neo- and adjuvant therapy might increase tumour control in these difficult-to-treat patients. Patients combining either high serum AFP levels, infiltrative form or MTM-HCC histological subtype represent 30% of BCLC A stage HCC patients in expert centers, and are the ideal candidates for such trials.

Therefore, the first aim of this proposal is to assess the benefit of lenvatinib in neo- and adjuvant setting combined with curative percutaneous ablation for BCLC A HCC patients considered at high risk of local recurrence (high AFP or infiltrative form or macrotrabecular massive subtype).

Multicenter, 19 hepatology or hepatoGastroenterology and radiology departments in 11 French hospitals (inclusion of patients in 10 centers).

A pilot interventional, prospective, multicenter study.

The design of study is summarized as follows:

* Neoadjuvant phase with lenvatinib for 21 days (rationale: compromise between expected benefit and acceptable tolerance without compromising ablation procedure)
* PA of HCC in a curative intent (radiofrequency, microwave or electroporation)
* Adjuvant phase with lenvatinib for 3 months (rationale: compromise between expected benefit and acceptable tolerance without compromising ablation procedure) Lenvatinib doses will be adapted according to SmPC.

Constitution of a biobank with :

* paraffin and frozen tumoral and non tumoral biopsy sampled at before and after one month of neoadjuvant lenvatinib (second biopsies at the time of the PA procedure)
* Serum, plasma samples before the neoadjuvant lenvatinib, before PA procedure, at 1,3 months of the adjuvant lenvatinib and at month 6.

Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative

Lenvatinib in Neo-adjuvant and Adjuvant Therapy for Poor-prognosis BCLC A HepatoCellular Carcinoma Treated by Percutaneous Ablation Procedure in a Curative Intent: Multicentre Pilot Therapeutic Trial

patients will meet this endpoint if they are alive with or without HCC recurrenceat 1and 2 years after EP. procedures. Causes and date of death will be specified when applicable during this timeframe.

Adverse events related : fatigue, arterial hypertension, hand-foot skin syndrome to Lenvatinib will be monitored according to manufacturer guidelines and recommendation

Absence of tumour cells (binary scale :0/1)

Assessment of intra and extra tumoral inflammatory infiltrate (semi quantitative scale: 0=non, 1=mild, 2=intense)

change in gene expression following sequential whole exome sequencing (binary scale 0/1 with clustering analyses)

Accounting for treatment returns. checking respect of scheduled lenvatinib administered

Consittution of a sequential biobank comprising liver tissue : histological outcome

Consittution of a sequential biobank comprising liver tissue : histological

Changes in PIGF (UI/mL), VEGF-A (UI/mL), VEGF-C (UI/mL), sVEGFR2 (UI/mL), sVEGFR3 (UI/mL), MET (UI/mL), sKIT (UI/mL), Ang2 (UI/mL), AFP (UI/mL), PIVKA (UI/mL) (changes expressed by median comparison)

Recurrence rate local will be assessed using imaging techniques as recommended by international guidelines (3-months US and MRI during two years). Patients who will meet primary endpoint will be alive 1 year afterPA procedure without evidence of local recurrence on 3-months US/MRI evaluations.

Evaluation performed by MRI : Assessment of complete response versus incomplete response (persistence of active tumour).

Evaluation performed by MRI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center	NCT03988543	Cancer	Patient Self-ma...	18 Years -	Northwestern University
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.	NCT00759382	Non Small Cell ...		18 Years -	European Lung Cancer Working Party
Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer	NCT03053310	Head and Neck		70 Years -	AZ Sint-Jan AV
Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma	NCT01456585	Adenocarcinoma ...	Gemcitabine CP-870,893	18 Years -	Abramson Cancer Center at Penn Medicine
Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative	NCT05113186	Hepatocellular ...	Lenvatinib Pill	18 Years - 99 Years	Assistance Publique - Hôpitaux de Paris
Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative	NCT05113186	Hepatocellular ...	Lenvatinib Pill	18 Years - 99 Years	Assistance Publique - Hôpitaux de Paris
Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center	NCT03988543	Cancer	Patient Self-ma...	18 Years -	Northwestern University

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