Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Death

Breast Neoplasms

Lung Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

All participants will engage in playing the end-of-life conversation game called "Hello", which involves answering open-ended questions about medical decision making and end-of-life issues.

To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

Other Name: Previously named "My Gift of Grace"

End-of-life conversation game called "Hello"

Lauren Van Scoy, MD

The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with breast, lung, and/or genito-urinary cancers treated at Penn State Cancer Institute and their loved ones perform advance care planning. The main questions it aims to answer are:

* What modifications and/or adaptations are necessary to Hello for use in cancer populations?
* How do different delivery models compare for recruitment in terms of feasibility and efficiency?

Participants will:

* Complete pre-game questionnaires
* Play the Hello game
* Complete post-game questionnaires
* Participate in a focus group

Previous studies conducted by the investigators have shown that the Hello game demonstrates successful ACP engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in ACP is an important aspect of care according to patients with advanced cancer. However, only 55% of patients with advanced cancer patients have participated in ACP. These patients have substantial bio-psycho-social stressors that distinguish their ACP needs from others. Tailoring established interventions that foster high quality conversations about medical treatment preferences and end-of-life issues (such as the Hello game) is critically important for this population given its unique needs. As evidenced by qualitative interviews with \>200 participants, the Hello game creates a safe environment for sensitive conversations about end-of-life issues and inspired sharing of rich perspectives, with no reported adverse events, excessive burden, or negative emotional effects. That said, the intervention must be adapted for patients with cancer, particularly those with advanced cancer and their caregivers.

Additionally, while several effective ACP interventions exist (including Hello), how best to disseminate these interventions has not been rigorously or systematically studied. In other ongoing and previous studies, the investigators have demonstrated success in both engaging individuals living in underrepresented communities in ACP and successfully enrolling them in interventional research about ACP. The investigators credit these successes to their unique intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to discuss end-of-life issues) by leveraging established community connections to recruit participants to participate in ACP interventions as well as research. In the CBDM, trusted community "hosts" (who are leaders from local hospice organizations, senior centers, health agencies) invite participants to attend an ACP event. They introduce the research team to the attendees who may choose to participate in the ACP activity, the research, or both. Hosts are provided with marketing materials and utilize their community network channels to advertise the event. This model allows for research to be conducted more easily within hard to reach and underserved communities such as Black, Hispanic and rural communities- much like the most remote communities across the PSCI's 28-county catchment area.

Patients with cancer, however, are unique, and may require an alternative approach that involves partnering with their oncology care team to introduce the concept of ACP and encourage participation in ACP and research. Notably, there is evidence that patients are more likely to engage in ACP when recommended by their physician, so how best to approach ACP for cancer patients is unknown. A common approach to ACP intervention research is to use a Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is recommended by the patient's clinician (rather than through community-based outreach groups). For this intervention delivery approach, research assistants support interactions between clinicians (providers or nurses) to find appropriate patients and garner interest in performing ACP. This model is commonly used to recruit patients for clinical trials, including ACP interventions. For patients with cancer, the HBDM may have some advantages over the CBDM, given the close bonds that form between a patient and clinical care team as they interact frequently during active treatments such as infusions and radiation that often span several hours and weeks. Leveraging these therapeutic relationships may support greater acceptance of opportunities to broach ACP than a community-based model, but this remains unknown.

Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning

Adapting an Advance Care Planning Intervention and Delivery Model for Use With Patients With Cancer and Their Caregivers

Group discussions held with patients with cancer and their caregivers to collect qualitative data on acceptability of the game, necessary modifications for use in patients with cancer and their caregivers, and other feedback and opinions on the game experience.

This 4-item short-version survey measures readiness to perform ACP.

This 17-item survey measures surrogate decision maker readiness to perform ACP.

This 8-item survey measures participants' satisfaction with the conversation. Each item is scored on a 1-7 scale with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1-7 with 7 indicating the highest conversation satisfaction.

This 3-item survey measures participants' perceived acceptability of the intervention.

Milton S. Hershey Medical Center

Professor of Medicine, Humanities and Public Health Sciences

Infections

Rare Diseases

Communicable Diseases

Prostatic Neoplasms

COVID-19

Carcinoma, Renal Cell

Kidney Neoplasms

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Renal Cell Carcinoma

Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.

Miguel Ángel Climent, M.D., Ph.D.

Javier Puente, M.D., Ph.D.

Aránzazu González del Alba, M.D., Ph.D.

Sergio Vázquez Estevez, M.D., Ph.D.

Natalia Vidal, M.D., Ph.D.

The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics.

SOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.

The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be:

1. Patient characteristics
2. Hospital center where the patient is recruited
3. Pathological history:

   Concomitant pathology Usual drug treatment
4. Tumor pathology:

   Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment
5. COVID-19 infection:

   Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date
6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected:

   Immunotherapy treatment line and type Start / end date and last dose previous infection of the treatment with immunotherapy Adverse effects
7. Prospective follow-up data (6 months from patient inclusion):

Date of start or restart of cancer treatment after infection Change / suspension of cancer treatment after COVID-19 Date of surgery in neoadjuvant patients Recurrence of COVID-19 Best response obtained Date of progression to cancer treatment Current status and date of last contact The study will use the data obtained from the patient's medical history, with no plans to use other sources.

The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; The decision to prescribe a specific treatment is clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, whether diagnostic or follow-up, that is not the usual clinical practice. Epidemiological methods will be used to analyze the collected data.

Description of the Population With Genitourinary Tumors and COVID-19

Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)

Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Age, gender, cancer type. Categorical variables will be presented as counts and percentages.

Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)

To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.

To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.

To evaluate in patients with Prostate Cancer (PCa) the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity

To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.

Evaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them.

Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.

delays / modifications in cancer follow-up or treatment regimens. The average delay time and the number of modifications will be evaluated.

It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology

Spanish Oncology Genito-Urinary Group

Urinary Bladder Neoplasms

Urologic Neoplasms

Urologic Diseases

Kidney Diseases

Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.

Subjects with prostate cancer amenable to a tumor biopsy.

Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.

Bone marrow biopsy

Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.

Tumor biopsy

Andrew Armstrong, MD, ScM

The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the host immune system will not be observed and therefore a preclinical model to study immunotherapy can be developed to study, understand and improve upon our current therapies. HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.

The secondary objective is to use patient tumor biopsy samples or circulating tumor cell samples to develop additional preclinical models of GU cancers, particularly prostate cancer, that are clinically relevant by generating additional PDXs.

Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers

Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning	NCT06028152	Breast Cancer Lung Cancer Genito Urinary ...	End-of-life con...	18 Years -	Milton S. Hershey Medical Center
Description of the Population With Genitourinary Tumors and COVID-19	NCT04578132	Covid19 Genito Urinary ...		18 Years -	Spanish Oncology Genito-Urinary Group
Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers	NCT03134027	Genito Urinary ... Bladder Cancer Kidney Cancer Prostate Cancer	Bone marrow bio... Tumor biopsy	18 Years -	Duke University

Spots Global Cancer Trial Database for genito urinary cancer