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NCT ID: NCT04270123 Completed - Breast Cancer Clinical Trials

An EORTC Study Updating the QLQ-BR23 to BR45

Start date: November 2, 2020
Phase:
Study type: Observational

Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible. According to sample size calculations, we will include a total of N =490 patients from 12 countries. Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).

NCT ID: NCT04264767 Completed - Cancer Clinical Trials

Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

Start date: April 17, 2019
Phase:
Study type: Observational

Nucleix EpiCheck® tests analyzes the methylation pattern in a panel of DNA methylation biomarkers and determines whether this pattern is consistent with cancer under test or with non-cancer tissue. This study is being performed as part of the development process of the Pan Cancer EpiCheck test which includes the identification of different methylation profiles in various cancer types and healthy controls.

NCT ID: NCT04259658 Completed - Cancer Clinical Trials

Histopathologic Effect of Calcium Electroporation on Cancer in the Skin

CAEP-B
Start date: April 20, 2020
Phase: Phase 2
Study type: Interventional

In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.

NCT ID: NCT04255030 Completed - Cancer Clinical Trials

An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

High-quality cancer care in Canada relies on family caregivers. Since cancer treatment is provided more and more in outpatient clinics, family caregivers now provide most of the support and care patients need when they return home. The problem is that caregivers often do not feel they have the knowledge and skills to fulfill this role, especially as caregivers often confront tasks once performed by health care professionals. As a result, caregivers experience high levels of burden and need more help to handle the demands of their role. Programs that enhance caregivers' knowledge and prepare them for their role can have positive effects on their well-being. However, these programs are not available in routine cancer care. They just take too much time and personnel and are too expensive. This limited access to resources reduces caregivers' ability to cope and affects their quality of life. If the ultimate goal is to integrate these programs in cancer care, cost-effective service delivery models are needed. One approach that rises to this challenge and is effective is the self-directed format. A self-directed format requires less support from clinicians and is available to individuals when it is most convenient to them. The research team recently developed and evaluated the first self-directed coping skills training intervention for cancer caregivers called Coping-Together. Although self-directed interventions offer the scalability needed for public health interventions, up to 60% of caregivers do not improve after receiving this type of intervention. These caregivers require more support. This innovative trial design will help determine whether changing the type and level of support provided can increase the number of caregivers who improve after receiving Coping-Together. This type of innovative trial design is more and more popular, but has never been used to enhance the feasibility, acceptability, and efficacy of caregiver interventions.

NCT ID: NCT04246021 Completed - Cancer Clinical Trials

Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

Start date: June 15, 2016
Phase: N/A
Study type: Interventional

This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

NCT ID: NCT04242667 Completed - Cancer Clinical Trials

Penn Biobank Return of Research Results Program

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.

NCT ID: NCT04242251 Completed - Cancer Clinical Trials

Novel Palliative Care Model for Advanced Cancer Patients: A Randomized Controlled Trial Study

SPARKLE2
Start date: February 8, 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial of the 'Supportive and Palliative care Review Kit in Locations Everywhere' (SPARKLE) intervention, an outpatient-based model of early palliative care. The SPARKLE intervention comprises regular symptom monitoring using questionnaires, early identification and prompt treatment of problems identified. Proactive screening for problems facilitates earlier palliative care interventions for advanced cancer patients, whenever needs arise.

NCT ID: NCT04241796 Completed - Cancer Clinical Trials

Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice

Start date: December 12, 2019
Phase: N/A
Study type: Interventional

PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. In cases with a "signal detected" test result (with a predicted or indeterminate tissue of origin (TOO)), the diagnostic work-up will not be dictated by the protocol, but will instead be coordinated by the ordering and treating medical team at the enrolling sites based on the participant's clinical condition, recommendations by each institution's clinical practices, and in consultation with the study investigator and interdisciplinary care team, as necessary. Additionally, proposed clinical care pathways, developed based on a review of guidelines from the National Comprehensive Cancer Network (NCCN), American College of Radiology (ACR) and other professional organizations, should be referenced by the medical team to determine the diagnostic work-up. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Performance of multi-cancer early detection test will be evaluated. Additionally, participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. Participants will be followed for approximately 12 months from the time of enrollment. Cancer status will also be assessed at the 12 month time point.

NCT ID: NCT04216641 Completed - Cancer Clinical Trials

Cancer, Nutrition and Taste

CANUT-1
Start date: February 26, 2020
Phase: N/A
Study type: Interventional

Cancer promotes weight loss; it can also lead to particular complications for patients during treatment. A team led by Dr Michael Sawyer, showed the deleterious impact of undernutrition on the benefits of chemotherapy. Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, ENT, bronchial tubes…). This undernutrition leads to major weight loss and wasting, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial in origin and has multiple consequences; it has its own prognostic value. Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. Altered taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients undergoing chemotherapy. The assessment of taste disorders in patients undergoing chemotherapy treatment is established through the use of questionnaires, interviews and taste tests. Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients undergoing chemotherapy. The objective of CANUT is to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms and in particular on interindividual differences in the perception and appreciation of food. In this study the investigators propose to adapt foods to best respond to sensory disorders related to the disease and/or treatment.

NCT ID: NCT04211727 Completed - Cancer Clinical Trials

Affinity: Hospital Trial

Start date: October 26, 2020
Phase:
Study type: Observational

Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)