Clinical Research Directory

The Effect of Mandala Coloring on Quality of Life in Cancer Patients

This study aims to determine the effect of mandala coloring on the quality of life in cancer patients. Conducting a quasi-experimental design with a pretest-posttest control group, the study will involve a total of 76 cancer patients hospitalized in an oncology ward. Participants will be assigned to either the experimental (mandala) group or the control group. At the baseline, data will be collected face-to-face using a Patient Information Form and the EORTC QLQ-C30 Version 3.0 Quality of Life Scale. Patients in the experimental group will be provided with a mandala coloring book and colored pencils, and they will practice mandala coloring for 30 minutes, at least twice a week, over a 3-week period. The control group will receive routine clinical care with no intervention. After 3 weeks, the EORTC QLQ-C30 scale will be re-administered to both groups to evaluate and compare changes in their quality of life.

A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment

Many clinical trials evaluating cancer treatments require patients to undergo testing for specific molecular markers as part of eligibility screening, typically using immunohistochemistry or sequencing. Because relatively few patients may carry a required marker, trial investigators often test large numbers of patients to identify the few who may ultimately qualify for enrollment. Pathology laboratories routinely produce hematoxylin-and-eosin (H\&E) slides during cancer diagnosis. Pathology foundation models-large neural networks pretrained on millions of histology images-have shown promise in predicting molecular characteristics from these slides. Researchers can use these models to build classifiers that predict specific molecular markers and prioritize patients for confirmatory testing. This study evaluates FATHOM (Facilitating Accrual through Tumor Histology and Omics Matching), an autonomous research system powered by large multimodal models. Its agents read registered clinical trial records, identify molecular markers used as enrollment criteria, build prediction models using pathology foundation models, select the individual models or model combinations that best meet prespecified criteria, set their decision thresholds, and determine whether to deploy them. Together, a prediction model, its decision threshold, and the decision to deploy it constitute an AI prediction policy. Before FATHOM runs, the investigators preregister the clinical trial records that its agents may read, the cutoff date that defines which trial information they may use, the rules governing the agents, and the analysis plan. The system timestamps and locks each policy immediately after an agent produces it. The investigators then apply the policies to archived patient slides and compare their predictions with existing molecular marker results. The primary outcome is the proportion of prespecified evaluation scenarios in which an agent-generated policy, compared with universal molecular testing, either enriches the population selected for confirmatory testing with marker-positive patients or safely spares patients from confirmatory testing while meeting prespecified performance criteria. This study analyzes existing pathology images and clinical trial records only. It does not enroll or contact patients, influence patient care, or affect participation in any clinical trial.

Optimising the Cancer Management of Older Patients by Early and Specific Geriatric Interventions.

The WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). Primary outcome is to reduce the risk of deterioration in global quality of life at 6 months during treatment and to prevent the onset of geriatric syndromes.

Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor

The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants. The main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.

Identifying and Mobilizing Personal Resources to Improve Well-Being in Cancer Participants Using the CAERES Protocol

Cancer patients often experience emotional distress, fatigue, and reduced quality of life that may not be fully addressed by medical treatment alone. Research suggests that helping patients identify and mobilize their personal strengths and resources may support their psychological well-being. However, structured psychosocial interventions focused on personal resources have not been widely tested in cancer rehabilitation settings. The goal of this clinical trial was to test the acceptability and feasibility of a 3-week psychosocial intervention designed to help adult cancer patients identify and mobilize their personal strengths to better cope with their illness. The intervention was based on the AERES tool (Auto-Evaluation des RESsources; in english : Resources Self-Assessment), a card-sorting instrument developed at the University of Lausanne for strength-based assessment in clinical populations. The main questions it aimed to answer were: * Was the CAERES (Cancer Auto-Evaluation of RESources) intervention acceptable and feasible for cancer patients undergoing oncological treatment or rehabilitation? * Did the intervention positively affect emotional well-being, self-efficacy, posttraumatic growth, cancer-related fatigue, anxiety, depression, and satisfaction with care? Researchers compared an immediate-intervention group with a waitlist control group (3-week delay before receiving the same intervention) to see if the intervention produced measurable effects on the targeted outcomes. Participants: * Completed an in-person AERES card-sorting session (1 to 2.5 hours) to identify personal strengths across three dimensions (personal qualities, hobbies and passions, and social/environmental resources) * Received a personalized written report identifying a targeted resource to develop * Engaged in a 3-week home-based reinforcement program with three weekly phone calls (15 minutes each) and three personalized written feedback reports * Completed validated questionnaires at three time points (baseline, post-intervention, follow-up) Recruitment was conducted at three sites in Italian-speaking Switzerland: the Rehabilitation Clinic of Novaggio (EOC/Ente Ospedaliero Cantonale), the Oncology Institute of Southern Switzerland (IOSI) in Bellinzona, and a private psycho-oncology practice in Lugano, with patient referrals supported by collaborating psycho-oncologists.