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NCT ID: NCT05139706 Recruiting - Cancer Clinical Trials

Montreal Immune-Related Adverse Events (MIRAE) Study

MIRAE
Start date: January 21, 2020
Phase:
Study type: Observational [Patient Registry]

Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.

NCT ID: NCT05129059 Recruiting - Cancer Clinical Trials

Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

NCT ID: NCT05128838 Recruiting - Cancer Clinical Trials

RISE (Reinvent, Integrate, Strengthen, Expand) Self-Management Program for Cancer Survivors: A Feasibility Study

Start date: May 25, 2022
Phase: Early Phase 1
Study type: Interventional

This is a prospective feasibility study using a convenience sample of cancer survivors from Cedars-Sinai and its surrounding catchment area. As this study will be primarily focused on optimization of the RISE (Re-invent, Integrate, Strengthen, Expand) protocol, there will be no control group or randomization of participants. The RISE intervention is informed by the principles of Lifestyle Redesign, an occupational therapy-based therapeutic technique focused on measurable, individually-tailored, health-related goals. All participants will complete the 13-session RISE intervention. Sessions will occur weekly or biweekly. Measures will be completed at baseline (session #0) and post-intervention (session #12), with repeat survey measures at midpoint (session #6). There will also be a follow-up timepoint 12 weeks after the final session, at which time some measures will be completed to assess long-term maintenance of self-efficacy improvement.

NCT ID: NCT05126875 Recruiting - Cancer Clinical Trials

Re-TREAT: Re-irradiation for Relapsed Brain Metastases

RE-TREAT
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

The Re-TREAT study is a prospective clinical, phase 2, interventional, single-arm, multicenter trial for patients with local relapse of one or more brain metastases. Patients with recurrence of one or more brain metastases that have previously been treated with stereotactic radiosurgey (SRS) are treated with repeated SRS. The aim is to evaluate the efficacy and toxicity of salvage SRS. The primary outcome is local control of the relapsed tumor and the secondary endpoints include toxicity as evaluated by the investigator and quality of life measured as a patient reported outcome. As an exploratory endpoint, the value of advanced MRI (magnetic resonance imaging) and PET (positron emission tomography) imaging as a biomarker for prediction of response to treatment or toxicity will be studied.

NCT ID: NCT05126823 Recruiting - Cancer Clinical Trials

Efficacy of a Combined ACT+ App Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Introduction: emotional and physical alterations frequently appear in cancer patients. In this sense, interventions based on acceptance and commitment therapy (ACT) show their efficacy to improve these symptoms through increased psychological flexibility, however, there is little evidence of the efficacy of ACT using combined modality (face-to-face + app), despite the fact that this application modality may have beneficial effects in this group of patients, who may see their participation in the interventions limited as a consequence of the disease. Method / design: Cancer patients will be randomly assigned to one of the following groups: (1) face-to-face ACT + app group, (2) face-to-face ACT group, and (3) group receiving usual treatment. The planned interventions last between 8 and 10 weeks and include experiential exercises, metaphors, discussions, and homework assignments to promote awareness and flexibility about thoughts and emotions associated with cancer. In the group that uses the app, exercises (mindfulness, breathing), reminder systems, recording, reinforcement and monitoring will also be provided. It is estimated that a total of 112 participants (38 per group) will be necessary, and four evaluations will be carried out: T0 (pre-treatment), T1 (post-treatment, T2 (follow-up at three months) and T3 (follow-up at six months). months). Hypothesis : The primary results that are expected to be obtained are a significant increase in the psychological flexibility of patients receiving treatment, with greater flexibility in the group receiving the combined intervention, evaluated with the AAQ-II. Furthermore, as secondary outcomes, it is expected to obtain significant improvements in anxiety and depression (HADS), quality of life (EORTC QLQ C-30), Fatigue (BFI), Insomnia (ISI) and post-traumatic growth (PTGI-SF). Hypothesis: the efficacy of the ACT-based intervention in cancer patients may be increased if the benefits of using a modality that combines face-to-face and not face-to-face are added to it.

NCT ID: NCT05122052 Recruiting - Cancer Clinical Trials

Effect of Gender on Distress and Fatigue in Cancer Patients

Start date: November 28, 2018
Phase:
Study type: Observational

Distress in cancer patients has been shown to be higher in females than males, but the behavior of distress during time in longitudinal prospective studies has not been studied, nor is it known if there are differences related to gender during time. These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories. The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types. It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women. We will also investigate if psychological factors (distress, anxiety and depression) affected antibody response and markers of COVID-19 vaccine activation (C-reactive protein, CRP and D-dimer) after 6 months from initial vaccination. Caregivers will also be interviewed to measure their burden with the Zarit Burden Interview. Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit. Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session. Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions.

NCT ID: NCT05118464 Recruiting - Cancer Clinical Trials

Effect of Dual-Task Training on Pediatric Oncology Patients

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

It is known that the treatment of children with cancer has negative effects on cognition, muscle strength, balance, and gait. Therefore, the aim of this study is to evaluate the effects of dual-task training, which is based on the principle of simultaneous performance of cognitive tasks and motor tasks, on muscle strength, balance, and gait.

NCT ID: NCT05112016 Recruiting - Cancer Clinical Trials

Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

TME-KSW
Start date: January 1, 2007
Phase:
Study type: Observational [Patient Registry]

The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer

NCT ID: NCT05096923 Recruiting - Cancer Clinical Trials

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

UNC-CAYACC
Start date: December 17, 2021
Phase:
Study type: Observational [Patient Registry]

Purpose: This study aims to create a registry of childhood, adolescent, and young adult patients with cancer (<40 years-old at cancer diagnosis), entitled the 'UNC Childhood, Adolescent, and Young Adult Cancer Cohort' (UNC-CAYACC). This resource will serve to support cancer outcomes research among pediatric and young adult cancer patients with a primary focus on enrolling patients treated as adolescents or young adults (AYAs, 15-39 years). Procedures: As appropriate for age, participants will complete physical and cognitive functional assessments; questionnaires to assess health-related quality of life and other patient-reported outcomes; will undergo body composition and anthropometric measurements; and will be asked to provide biospecimens for biobanking. Assessments will be collected (as possible) at diagnosis, during active treatment, following treatment completion, and annually in survivorship to assess outcomes throughout the treatment and survivorship trajectory. Sociodemographic and clinical information such as cancer treatment modalities and cumulative doses will be collected by medical record abstraction. Participants will be eligible to enroll at any time from diagnosis through survivorship. This registry will provide data to better understand the manifestations of accelerated aging and key contributing factors among children, adolescents, and young adults with cancer.

NCT ID: NCT05094804 Recruiting - Cancer Clinical Trials

A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents

Start date: September 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with advanced solid tumors.