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Oncology clinical trials

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NCT ID: NCT04179305 Completed - Critical Illness Clinical Trials

Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2

Oncolo-GIST
Start date: October 25, 2020
Phase: N/A
Study type: Interventional

When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However our prior studies shown that even when patients only have months left to live, most do not understand that their cancer is incurable and that it is late/end-stage. Dying cancer patients who fully understand their prognosis are able to make more informed decisions and are therefore more likely to engage in advanced care planning, and receive care what in consistent with their values and preferences. They are also in a better position to avoid burdensome, non-beneficial care. The investigator developed Oncolo-GIST in order to help increase the number of patients who fully understand their prognosis and its implications. Oncolo-GIST is an intervention aimed at enhancing clinicians' communication with patients by teaching them to relay information both sensitively and using simple terminology. The Oncolo-GIST training will provide instruction in areas such as how to introduce the topic of prognosis (describe scan results as "worse"), how to phrase the prognosis itself ("likely months, not years"), how to explain expected treatment outcomes (e.g., "not expected to be cured by treatment") and how to describe expected treatments impact on quality of life - that is, whether the anticancer treatment is likely to make them feel overall better or worse. The training materials consist of a manual and a set of videos that act out situations described in the manual. The second phase of this study will be a randomized controlled trial. The investigator will recruit (n=50) adults with metastatic GI or lung cancers with scan results that reveal progression (worsened disease) on an initial systemic treatment; that is, patients whose life-expectancy can reliably be estimated to be months, not years. Medical oncologists (n=4) who care for these patients will also be consented for study participation and half (n=2) will be randomized to receive the Oncolo-GIST training. Patients will be assessed by trained research staff in the week prior to a scheduled meeting with their oncologist to discuss the scan results. This will provide patients' baseline levels of prognostic understanding and enable the investigator to determine how the intervention relates to pre-post scan visit changes in prognostic understanding. Patients will be assessed post-scan within a week of that progressive scan visit. The assessment battery that will be administered at these time-points will measure the patient's degree of prognostic understanding, the primary outcome of the study. Other outcomes that will be measured by the assessment battery include the patients quality of life, therapeutic alliances of the patient, whether or not a DNR was ordered, the care received by the patient, whether or not the patient preferred greater quality of longer quantity of life, and whether or not the patients received "value-consistent" care.

NCT ID: NCT04168814 Completed - Quality of Life Clinical Trials

Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients in Spain: the NutriOncoSearch (NOS) Study

NOS
Start date: June 10, 2020
Phase:
Study type: Observational

Malnutrition is a common medical problem in oncology patients. It is well known that the presence of malnutrition negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality. The new knowledge of cancer biology has made it possible to know the mechanisms of cancer progression. New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the antitumor capacity of the immune system. However, these treatments have different toxicities than classic and anachronistic treatments such as chemotherapy and radiotherapy, including alterations in glucose metabolism, endocrinopathies, rhabdomyolysis, etc. that can alter both the patient's nutritional status and quality of life. Additionally, a deficient nutritional status can have an impact on the intestinal microbiota, compromising the efficacy of the new antitumor treatments. The principal objective of this study is to characterize the nutritional status of the cancer outpatient receiving immunotherapy through a screening performed in Hospital consultations in Spain. Secondary Endpoints are (a). To describe the percentage of patients that receive nutritional counseling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics.

NCT ID: NCT04158908 Completed - Critical Illness Clinical Trials

Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1

Oncolo-GIST
Start date: January 17, 2020
Phase:
Study type: Observational

When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However the investigator's prior studies shown that even when patients only have months left to live, most do not understand that their cancer is incurable and that it is late/end-stage. Dying cancer patients who fully understand their prognosis are able to make more informed decisions and are therefore more likely to engage in advanced care planning, and receive care what in consistent with their values and preferences. They are also in a better position to avoid burdensome, non-beneficial care. The investigator developed Oncolo-GIST in order to help increase the number of patients who fully understand their prognosis and its implications. Oncolo-GIST is an intervention aimed at enhancing clinicians' communication with patients by teaching them to relay information both sensitively and using simple terminology. The Oncolo-GIST training will provide instruction in areas such as how to introduce the topic of prognosis (describe scan results as "worse"), how to phrase the prognosis itself ("likely months, not years"), how to explain expected treatment outcomes (e.g., "not expected to be cured by treatment") and how to describe expected treatments impact on quality of life - that is, whether the anticancer treatment is likely to make them feel overall better or worse. The training materials consist of a manual and a set of videos that act out situations described in the manual. The first phase of this study will consists of two parts: 1. Stakeholder Interviews: The investigator will obtain feedback from relevant stakeholders/key informants on Oncolo-GIST Version 1.0 manual and videos using a version of the Delphi method in which the investigator will interview bereaved family caregivers of advanced cancer patients (n=10) and oncology clinicians who care for patients with advanced gastrointestinal (GI) and thoracic (lung) cancers (n=10). The information gathered will be used to develop Oncolo-GIST Version 2.0. 2. Open Trial: The investigator will conduct an initial open trial of the Oncolo-GIST intervention to 10 advanced cancer patients (N=10) by participant clinicians (n=8). This will help us gather information about the feasibility and acceptability of the intervention to patients and oncologists and also inform changes for Oncolo-GIST Version 2.0. This phase will be followed by second phased (listed in a separate record in ClinicalTrials.gov) that will include a randomized controlled trial of Oncolo-GIST Version 2.0. The record is titled "Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2" and its NCT ID# isNCT04179305.

NCT ID: NCT04134429 Completed - Oncology Clinical Trials

Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Start date: November 29, 2019
Phase:
Study type: Observational

In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

NCT ID: NCT03988777 Completed - Breast Cancer Clinical Trials

Magnetic Seed Localisation for Nonpalpable Breast Lesions

Start date: September 10, 2018
Phase:
Study type: Observational

Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.

NCT ID: NCT03984773 Completed - Oncology Clinical Trials

Machine-Generated Mortality Estimates and Nudges to Promote Advance Care Planning Discussion Among Cancer Patients

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

This study will use a stepped-wedge cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality.

NCT ID: NCT03952767 Completed - Oncology Clinical Trials

The STEPP Study: Sensors To Evaluate Physical Performance

STEPP
Start date: April 24, 2019
Phase: N/A
Study type: Interventional

This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).

NCT ID: NCT03951090 Completed - Oncology Clinical Trials

Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients

Start date: April 25, 2016
Phase: N/A
Study type: Interventional

This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer.

NCT ID: NCT03948477 Completed - Breast Cancer Clinical Trials

Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy

PantoCIN
Start date: June 10, 2019
Phase: Phase 2
Study type: Interventional

This study explores whether a commonly used medication called Pantoprazole can help prevent delayed nausea and vomiting from chemotherapy for early breast cancer. Delayed nausea, and occasionally vomiting, can occur after breast cancer chemotherapy, affecting quality of life. A potential cause of these delayed side effects is that the chemotherapy may cause stomach irritation. Pantoprazole is commonly used to treat stomach irritation by reducing stomach acid, which may in turn improve nausea and/or vomiting. Patients undergoing breast cancer chemotherapy before or after primary surgery will be invited to participate in the study. They will be asked how much nausea or vomiting they have with and without Pantoprazole from Day 2 until 5 after they receive chemotherapy. All participants will still receive all of the usual anti-sickness medications, which are very effective in preventing sickness in the first 24 hours after treatment, but not for delayed symptoms. Information from the study may lead to a change in practice with patients using Pantoprazole to reduce the risks of delayed nausea and vomiting.

NCT ID: NCT03855969 Completed - Oncology Clinical Trials

Central Venous Access Device Removal in Cancer Patients

Start date: March 1, 2019
Phase:
Study type: Observational

Background: Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective. The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population. Trial objectives: The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years. The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device. At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.