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Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain (PRESENCE)

Steffi Siebert, MPH - presencestudy@pitt.edu

NCT06374238
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Inclusion Criteria:

• Aged 16 to 39 years of age at time of enrollment
• Sickle Cell Disease diagnosis of any genotype based on referral or documentation
• Reports chronic pain (≥4 days/week for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days/week for past 3 months or more) OR B) Taking pain medication (≥4 days/week for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days/week for past 3 months or more)
• Access to an iOS or Android mobile device with internet access
Exclusion Criteria:

• Unable to speak or read English
• Prior hematopoietic stem cell transplant for sickle cell disease
• Not living in the United States throughout enrollment and duration of the study period
BEHAVIORAL: CBT+ Health coach, BEHAVIORAL: CBT w/o Health Coach ( self-guided), BEHAVIORAL: Usual Care
Pain, Sickle Cell Disease
Sickle Cell Disease, Pain management, Cognitive Behavioral Therapy, Wellness
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Study Locations

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Location Contacts
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Kevin Guerrero - (kguerrero@lueriechildrens.org)
Children's Healthcare of Atlanta Atlanta, Georgia Katyria Thornton - (katyria.thornton@choa.org) Vontarius Howard Jesse - (vontarius.howard@choa.org)
Connecticut Children's Medical Center Hartford, Connecticut Christopher Theriault - (ctheriault@connecticutchildrens.org)
East Carolina University Health Medical Center Greenville, North Carolina Toria Wilson - (wilsonto22@ecu.edu)
Rutgers New Jersey Medical School Newark, New Jersey Kim White - (whiteka@rwjms.rutgers.edu)
The Regents of the University of Michigan Ann Arbor, Michigan Anela Mukherjee - (mukherja@med.umich.edu)
UCLA Mattel Children's Hospital Ronald Reagan Hospital Los Angeles, California Debbie Argueta Rufino - (darguetarufino@mednet.ucla.edu)
UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Alex Berkebile - (berkebileak@upmc.edu) Amy Travis - (travisam@upmc.edu)
UPMC University of Pittsburgh Classical Hematology Adult Clinic Pittsburgh, Pennsylvania Steffi Siebert, MPH - (presencestudy@pitt.edu)
University of Rochester Medical Center Rochester, New York Priya Kaushal - (priya_kaushal@urmc.rochester.edu)
University of South Alabama Medical Center Mobile, Alabama Jessica King - (jlking@health.southalabama.edu) T'Shemika Perryman - (tperryman@health.southalabama.edu)
Virginia Commonwealth University Richmond, Virginia Danie Sop, PhD - (daniel.sop@vcuhealth.org)
Wake Forest Baptist Hospital Durham, North Carolina Julie Fountain - (Julie.Fountain@Advocatehealth.org)
Weil Cornell Medical College New York, New York Masiel Infante - (mai4011@med.cornell.edu)

A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com

NCT06989437
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Key inclusion Criteria: * Signed Informed Consent Document * Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma * Cachexia defined by Fearon criteria of weight loss * Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy * ECOG PS ≤1 with life expectancy of at least 4 months Key
Exclusion Criteria:
* Current active reversible causes of decreased food intake * Cachexia caused by other reasons * Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification * Left ventricular ejection fraction \<50% * Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization * History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody * History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients * Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases * Inadequate liver function * Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2
DRUG: ponsegromab, DRUG: placebo
Cachexia, Metastatic Pancreatic Ductal Adenocarcinoma
pancreatic cancer, metastatic cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
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Study Locations

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AZ Turnhout - Campus Sint-Elizabeth Turnhout, Antwerpen
Addenbrooke's Hospital Cambridge,
Affiliated Hospital of Hebei University Baoding,
Aichi Cancer Center Hospital Nagoya, Aichi-ken
Anhui Provincial Hospital Hefei,
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Jalisco
Apotheke am Universitätsklinikum Leipzig Leipzig, Saxony
Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta
Asan Medical Center Seoul, Seoul Teukbyeolsi
Atlantic Health System / Morristown Medical Center Morristown, New Jersey
Atlantic Health System / Overlook Medical Center Summit, New Jersey
Azienda Ospedaliera Universitaria Careggi Florence, Tuscany
Azienda Ospedaliera Universitaria Ospedali Riuniti - Foggia Foggia,
Azienda Ospedaliero Universitaria delle Marche Ancona,
Baylor Scott & White Vasicek Cancer Treatment Center Temple, Texas
Beijing Tsinghua Changgung Hospital Beijing,
CARTI Cancer center Little Rock, Arkansas
CHA Bundang Medical Center, CHA University Seongnam-si, Kyǒnggi-do
CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi, Quebec
Cancer Care Specialists of Illinois Decatur, Illinois
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon O'Fallon, Illinois
Cancer Hospital Chinese Academy of Medical Science Langfang, Hebei
Cancer Hospital Chinese Academy of Medical Science Langfang, Hebei
Cardiology Associates, Inc ‘Aiea, Hawaii
Cedars-Sinai Cancer at Cedars-Sinai Medical Center Los Angeles, California
Central Arkansas Radiation Therapy Institute, dba CARTI Pine Bluff, Arkansas
Central Arkansas Radiation Therapy Institute, dba CARTI Pine Bluff, Arkansas
Central Arkansas Radiation Therapy Institute, dba CARTI Pine Bluff, Arkansas
Central Arkansas Radiation Therapy Institute, dba CARTI Pine Bluff, Arkansas
Centre Hospitalier Universitaire de Poitiers Poitiers, Vienne
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre Greenfield Park, Quebec
Centro de Atención e Investigación Cardiovascular del Potosí S.C. San Luis Potosí City,
Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca
Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California
Chiba Cancer Center Chiba, Chiba
China Medical University Hospital Taichung,
Chittaranjan National Cancer Institute Kolkata, West Bengal
Cliniques Universitaires Saint-Luc Brussels, Bruxelles-capitale, Région de
Decatur Memorial Hospital Decatur, Illinois
Fakultna Nemocnica Trnava Trnava,
Fakultna nemocnica Trencin Trenčín, Trenčín Region
Fakultna nemocnica s poliklinikou Nove Zamky Nové Zámky,
Fred Hutchinson Cancer Center Seattle, Washington
Froedtert Hospital and the Medical College of Wisconsin Milwaukee, Wisconsin
Fujian Cancer Hospital Fuzhou, Fujian
Georgetown University Medical Center Washington D.C., District of Columbia
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy Washington D.C., District of Columbia
Grand Hopital de Charleroi Charleroi, Hainaut
Guangdong General Hospital Guangzhou,
Gustave Roussy Villejuif, Val-de-marne
Guy's & St Thomas' NHS Foundation Trust London,
H.R.U Málaga - Hospital General Málaga,
Hadassah Medical Center Jerusalem, Jerusalem
Hammersmith Hospital London,
Henri Mondor Hospital Créteil, Val-de-marne
Henry-Joyce Cancer Clinic Nashville, Tennessee
Hope and Healing Clinical Research LLC Hinsdale, Illinois
Hope and Healing Clinical Research LLC New Lenox- Research Department New Lenox, Illinois
Hospital Clinic de Barcelona Barcelona,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Moinhos de Vento Porto Alegre, Rio Grande do Sul
Hospital Santa Rita de Cassia Vitória, Espírito Santo
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario Central de Asturias Oviedo, Principality of Asturias
Hospital Universitario Ramon y Cajal Madrid,
Houston Methodist Hospital Houston, Texas
Huzhou Central Hospital Huzhou, Zhejiang
Hôpital Universitaire Paul Brousse Villejuif,
ICON Cancer Centre - Kurralta Park Kurralta Park, South Australia
Icahn School of Medicine at Mount Sinai New York, New York
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Icon Cancer Centre Hobart Hobart, Tasmania
Inha University Hospital Jemulpo-gu, Incheon
Inje University Haeundae Paik Hospital Busan,
Institut Jules Bordet Brussels,
Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region
Invision, LLC Honolulu, Hawaii
JHU Oncology Central Kit Services Baltimore, Maryland
Jack & Sheryl Morris Cancer Center New Brunswick, New Jersey
Jewish General Hospital Montreal, Quebec
Johns Hopkins Hospital Baltimore, Maryland
Kagawa University Hospital Kita-gun, Kagawa-ken
Kanagawa Cancer Center Yokohama,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Keimyung University Dongsan Hospital Daegu, Taegu-kwangyǒkshi
Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie Leipzig, Saxony
Klinikum rechts der Isar der Technischen Universitat Munchen München,
Kyushu University Hospital Fukuoka,
Levine Cancer Institute Charlotte, North Carolina
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
MHAT - Sveta Sofia EOOD Sofia,
MHAT for Women's Health Nadezhda Sofia,
Massey Cancer Center Clinical & Translational Research Lab Richmond, Virginia
Mayo Clinic Rochester, Minnesota
Mayo Clinic Rochester, Minnesota
Mayo Clinic Cancer Center Outpatient Pharmacy Rochester, Minnesota
Mayo Clinic Hospital Phoenix, Arizona
Mayo Clinic Pharmacy Jacksonville, Florida
Medical Center Futuremeds Plovdiv,
MidAmerica Cancer Care - American Oncology Partners Kansas City, Missouri
MidAmerica Cancer Care- American Oncology Partners Merriam, Kansas
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie München, Bavaria
Narodny Onkologicky Ustav Bratislava,
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Masovian Voivodeship
National Cancer Center Hospital Chūōku,
National Cancer Center Hospital East Kashiwa, Chiba
National Cheng Kung University Hospital Tainan,
National Hospital Organization Kyushu Cancer Center Fukuoka,
National Taiwan University Hospital Taipei,
Nebraska Medicine Omaha, Nebraska
Nebraska Medicine - Village Pointe Omaha, Nebraska
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s. Michalovce,
Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda Milan, Milan
OHSU Center for Health & Healing 1 Portland, Oregon
OSHU Center for Health and Healing 2 Portland, Oregon
Oncocentro Belo Horizonte, Minas Gerais
Oncology Investigational Drug Service (IDS) Baltimore, Maryland
Oregon Health and Science University Portland, Oregon
Pan American Center for Oncology Trials, LLC San Juan,
Pan American Center for Oncology Trials, LLC San Juan,
Pan American Center for Oncology Trials, LLC - Dorado Office Dorado,
Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayagüez,
Peking Union Medical College Hospital Beijing,
Premier Imaging Kansas City, Missouri
Princess Margaret Cancer Centre - University Health Network Toronto, Ontario
Providence Medical Foundation Santa Rosa, California
Qilu Hospital of Shandong University Jinan, Shandong
RWJ University Hospital Somerset, Steeplechase Cancer Center Somerville, New Jersey
Rabin Medical Center Petah Tikva, Central District
Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi
Rambam Health Care Campus Haifa, Heifa
Renown Health Medical Oncology Reno, Nevada
Renown Office of Clinical Research Reno, Nevada
Renown Regional Medical Center Reno, Nevada
Royal Free Hospital London,
Royal Marsden Hospital (Chelsea) London,
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai Municipality
Rutgers Cancer Institute New Brunswick, New Jersey
Rwj University Hospital Somerset Somerville, New Jersey
Samsung Medical Center Seoul,
Sana Klinikum Lichtenberg Berlin,
Sawai Man Singh Medical College Hospital (SMS Hospital) Jaipur, Rajasthan
Second Hospital of Lanzhou University Lanzhou, Gansu
Seoul National University Bundang Hospital Seongnam,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
Shanghai General Hospital Shanghai,
Sheba Medical Center Ramat Gan,
Shizuoka Cancer Center Nagaizumi-cho, Shizuoka
Shoalhaven District Memorial Hospital Nowra, New South Wales
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang
Sourasky Medical Center Tel Aviv, TELL ABĪB
Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o. Tomaszów Mazowiecki,
St. Joseph Medical Center Kansas City, Missouri
St. Marianna University Hospital Kawasaki, Kanagawa
Sunnybrook Research Institute Toronto, Ontario
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie Olsztyn, Warmian-Masurian Voivodeship
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie Koszalin,
Taipei Veterans General Hospital Taipei,
Tata Memorial Hospital Mumbai, Maharashtra
The Cancer Institute Hospital of JFCR Koto-ku, Tokyo
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul]
The Clatterbridge Cancer Centre Liverpool,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Xi'An Jiaotong University Xi'an, Shaanxi
The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan
The First Hospital of Shanxi Medical University Taiyuan, Shanxi
The Kirklin Clinic of UAB Hospital Birmingham, Alabama
The Ottawa Hospital - General Campus Ottawa, Ontario
The Second Hospital of Dalian Medical University Dalian, Liaoning
The University of Alabama at Birmingham Birmingham, Alabama
The University of Hong Kong-Shenzhen Hospital Shenzhen, Guangdong
The University of Osaka Hospital Suita, Osaka
UC Irvine Health Orange, California
UC San Diego Koman Family Outpatient Pavilion La Jolla, California
UC San Diego McGrath Outpatient Pavilion - Hillcrest San Diego, California
UC San Diego Medical Center - Bankers Hill San Diego, California
UC San Diego Medical Center - Encinitas Encinitas, California
UC San Diego Medical Center - Hillcrest San Diego, California
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla, California
UC San Diego Medical Center - Rancho Bernardo San Diego, California
UC San Diego Medical Center - Vista Vista, California
UC San Diego Moores Cancer Center La Jolla, California
UC San Diego Sulpizio Cardiovascular Center La Jolla, California
UCI Health - Irvine Irvine, California
UCLA Department of Medicine - Hematology/Oncology Los Angeles, California
UCLA Hematology/Oncology - Santa Monica Santa Monica, California
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill, North Carolina
UZ Leuven Leuven,
United Imaging Consultants Lenexa, Kansas
Unity Health Toronto, St. Michael's Hospital Toronto, Ontario
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Dresden, Saxony
Universitaetsklinikum Duesseldorf Düsseldorf, North Rhine-Westphalia
University Cancer & Blood Center, LLC Athens, Georgia
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University Multiprofile Hospital for Active Treatment Sofiamed Sofia,
University of Hawaii Cancer Center Honolulu, Hawaii
University of Kentucky Healthcare - Markey Cancer Center Lexington, Kentucky
University of Kentucky Medical Center Lexington, Kentucky
University of Kentucky Research Foundation Lexington, Kentucky
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO) Lexington, Kentucky
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina Hospitals at Hillsborough Hillsborough, North Carolina
University of Rochester Medical Center Rochester, New York
University of Texas Southwestern Medical Center Dallas, Texas
University of Texas Southwestern Medical Center - Simmons Cancer Center Dallas, Texas
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital Dallas, Texas
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital Dallas, Texas
University of Washington Medical Center Seattle, Washington
Universität Leipzig - Med. Fakultät Leipzig, Saxony
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan,
VCU Health Short Pump Pavilion Richmond, Virginia
VCU Health Stony Point Richmond, Virginia
VCU Health Tappahannock Hospital Tappahannock, Virginia
VCU Medical Center Gateway Building Richmond, Virginia
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi, National Capital Territory of Delhi
Venkateshwar Hospital New Delhi, National Capital Territory of Delhi
Virginia Commonwealth University Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia
Virginia Mason Medical Center Seattle, Washington
Vychodoslovensky Onkologicky ustav a.s. Košice,
Wakayama Medical University Hospital Wakayama,
Wakayama Minami Radiology Clinic Wakayama-shi Kimiidera 870-2, Wakayama
Western General Hospital Edinburgh, Midlothian
Western Health-Sunshine & Footscray Hospitals St Albans, Victoria
Westmead Hospital Northmead, New South Wales
Yamaguchi University Hospital Ube, Yamaguchi
Zhongshan Hospital Fudan University Shanghai,