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Cancer clinical trials

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NCT ID: NCT03919214 Not yet recruiting - Hypertension Clinical Trials

Hypertension Management in Cancer Patients

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

The investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Further, the investigators propose to develop an automated EHR (electronic health record) messaging system utilizing the home blood pressures that will be sent to the participant's PCP, with copies to the participant and the primary oncologist. This is a 12-week prospective non-randomized implementation study. 40 patients who are 18-74 years old who fall under the following criteria will be screened: 10 women with Stage 1-III breast cancer who are receiving either an anthracycleine of antiHER2 therapy, 10 men with prostate cancer on ADT, 10 individuals with CLL on ibrutinib therapy, and 10 individuals who are hematopoietic stem cell transplantation (HSCT) survivors. In Phase 1 (Weeks 1-4) of the study, participants will self-monitor their blood pressure using the QardioArm wireless upper arm blood pressure monitor 3 times per week. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by an abnormal weekly average systolic or diastolic blood pressure. The investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the primary care provider's clinical decision making. {Participants will be asked to complete a paper survey, upon enrollment, that will include life chaos and medication adherence questions. There will also be an end-of-study feedback survey (usability and acceptability questions through REDCap) for both the participants and their primary care providers. This is an implementation study with a descriptive analysis. The data generated from the study will be used in future studies, including testing of different interventions aimed at optimizing blood pressure control among patients on active cancer therapy. This study presents no greater than minimal risk to the subjects and adverse events are not anticipated.

NCT ID: NCT03916783 Not yet recruiting - Cancer Clinical Trials

Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS

Start date: June 2019
Phase: N/A
Study type: Interventional

This study will tailor and explore the short-term preliminary outcomes of an existing evidence-based Economic Empowerment (EE) Intervention, Suubi (Hope in Luganda -local Ugandan language), on access to pediatric cancer diagnosis, care, and treatment adherence among youth living with HIV (YLWHIV) with suspected cancers. The study will specifically address the following aims/research questions: Aim 1. Identify confirmed and suspected cancer cases in a cohort of >3000 HIV+ youth (ages10-24) seen at approximately 39 clinics in seven districts heavily affected by HIV/AIDS in southern Uganda. Aim 2. Enhance the Suubi EE intervention by including an educational component addressing misconceptions about cancer (Suubi4Cancer) and explore the acceptability and preliminary impact of Suubi4Cancer on short-term outcomes. Aim 3. Explore multi-level factors (individual, family, cultural) impacting participants' participation in and experiences withSuubi4Cancer.

NCT ID: NCT03915288 Completed - Cancer Clinical Trials


Start date: November 2015
Phase: N/A
Study type: Interventional

Introduction: Exercise programs focused on moderate intensity continuous training (MICT) and HIIT (High Intensity Interval Training) are shown as an effective treatment to mitigate the effects of cancer. Objective: To determine and compare the effects of MICT vs. HIIT on the cardiometabolic and psychosocial variables of the cancer patient. Methods and materials: Randomized controlled trial of 3 years and 4 months in participants with stage II cancer divided into 3 groups (MICT, HIIT and control group). Risk factors, blood samples for glycemia and lipid profile were identified. In addition, 6-minute walk, stress test for maximum heart rate (HRM), anthropometry, quality of life, fatigue, sarcopenia, depression, anxiety, clinical and hemodynamic parameters. All tests were done before and after 36 training sessions of 70 minutes, 3 times a week.

NCT ID: NCT03910296 Recruiting - Cancer Clinical Trials

Acceptance and Commitment Therapy (ACT) - Based Treatment Development for Cancer Patients Treated for Pain

Start date: February 20, 2019
Study type: Observational

This research study is being done to determine the efficacy of an intervention for psychological symptoms that patients diagnosed with cancer may experience.

NCT ID: NCT03909464 Recruiting - Cancer Clinical Trials

Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy

Start date: November 29, 2017
Study type: Observational

Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge. Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy. Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI. Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.

NCT ID: NCT03909386 Not yet recruiting - Cancer Clinical Trials

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Start date: May 1, 2019
Study type: Observational

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified. A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

NCT ID: NCT03905876 Recruiting - Cancer Clinical Trials

Psychological Distress Experience

Start date: January 21, 2019
Phase: N/A
Study type: Interventional

While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).

NCT ID: NCT03899155 Not yet recruiting - Cancer Clinical Trials

Pan Tumor Nivolumab Rollover Study

Start date: May 15, 2019
Phase: Phase 4
Study type: Interventional

Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

NCT ID: NCT03897166 Recruiting - Cancer Clinical Trials

Trimodal Imaging Before Radiotherapy

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

In oncology, personalized medicine is progressing by providing increasingly tumor- and patient-specific care. Thus, medical imaging allows precise morphological and functional characterization of the tumor by volume measurements, used in particular in radiotherapy to define the macroscopic tumor volume (GTV), and radiomic measurements that correspond to a recent concept of extraction of textural parameters and/or tumor shape (tumor heterogeneity, tumor invasiveness...). Precise characterization of the patient is also possible by anthropometric measurements (measurements of total muscle mass, visceral adipose tissue mass...) which can be important predictive and prognostic factors and which are generally estimated more accurately in imaging than by using mathematical formulas. However, these measurements are partly dependent on the imaging acquisition mode (PET, CT or MRI). The volume measurements, and therefore the GTV, are thus different depending on the imaging used. Studying these differences is important because no single imaging technique encompasses all potential GTV regions but, on the other hand, a combination of anatomical and functional information could improve tumor delineation. Beyond this volume analysis, the extraction of radiomic characteristics seems very promising in radiotherapy with however many limitations to be overcome, linked in particular to the data acquisition mode. Concerning anthropometric measurements, CT and MRI have become essential techniques for precise anatomical quantification, particularly of lean mass, visceral adipose tissue or muscle mass, but automatic measurement techniques for these parameters have yet to be defined, particularly during CT or MRI acquisitions associated with PET for attenuation correction. To identify useful volume, radiomic and anthropometric characteristics, medical imaging thus requires prospective cohorts of patients with comparable cancer histologies and standardized images acquired by different modalities (e. g. PET, CT or MRI) during the pre-treatment assessment before similar treatments. The purpose of this study is to create a prospective cohort to study volume, radiomic and anthropometric characteristics by taking advantage of the recent installation of MRI in the medical imaging department of the Henri Becquerel Cancer Center (HBCC), Rouen, France, allowing PET/MRI to be performed and by taking advantage of the collaboration between the radiotherapy and medical imaging departments of the HBCC.

NCT ID: NCT03893955 Not yet recruiting - Cancer Clinical Trials

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: April 30, 2019
Phase: Phase 1
Study type: Interventional

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 + ABBV-368 with and without ABBV-181 in participants with selected solid tumors. This study consists of 2 main parts, dose-escalation and dose-expansion phases. The trial will begin with dose escalation in Arm A (ABBV-927 + ABBV-368) which determines the recommended Phase 2 dose (RP2D)/maximum-tolerated dose (MTD) of ABBV-927 when administered with ABBV-368. Once the RP2D/MTD is defined in Arm A, enrollment will begin in the following arms: Arm 1 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm 2 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm B (ABBV-927 + ABBV-368 + ABBV-181) dose escalation. Once the RP2D/MTD is defined in Arm B, enrollment will begin in the following arms: Arm 3 (ABBV-927 + ABBV-368); Arm 4 (ABBV-927 + ABBV-368 + ABBV-181); Arm 5 (docetaxel).