Kahului

Researchers are evaluating the Cost Communication and Financial Navigation (CostCOM) program to see how it affects cancer patients' ability to stick to their care plans and manage financial stress caused by high out-of-pocket medical costs. Financial hardship from cancer treatment can cause delays or stops in care and lower quality of life. This study compares usual care with CostCOM, which offers financial counseling, education, and resource connections to reduce financial barriers and ease financial burden. Patients with newly diagnosed solid cancers are randomly assigned to one of two groups. One group receives a brochure about financial navigation services, while the other group receives the usual financial care plus CostCOM counseling sessions lasting about one hour, given within 30 days after enrollment and then again at 3, 6, and 12 months. Non-patient participants involved in the study complete surveys and participate in in-depth interviews 15 to 39 months after the first patient enrollment. Participants are monitored for 12 months after completing the intervention. Researchers collect patient-reported information on care adherence affected by costs, financial hardship, worry about finances, quality of life, and satisfaction with care. They also assess patient and provider experiences with the CostCOM program, the accuracy of cost estimates communicated, and neighborhood characteristics. The study aims to understand how CostCOM impacts patients over time and their use of financial navigation resources.

Researchers are investigating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have a less than optimal PSA response after 6 to 12 months of androgen-targeting therapy. This phase III, open-label, randomized international trial compares the effectiveness of Docetaxel combined with standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI) versus ADT and ARPI alone. The study focuses on men with metastatic prostate adenocarcinoma who have a suboptimal PSA decline following initial hormone therapy. Participants receive standard ADT and an ARPI such as abiraterone, enzalutamide, apalutamide, or darolutamide, which are assigned before enrollment. At enrollment, patients are randomized to receive either the addition of Docetaxel chemotherapy or no chemotherapy alongside their hormone therapy. The goal is to assess whether this combination reduces cancer growth or spread compared to hormone therapy alone. Treatment begins within five working days after enrollment, with close monitoring throughout the study. Throughout the trial, participants undergo regular assessments including PSA measurements to monitor cancer activity and overall survival tracked at 39 months. Eligibility requires stable organ function, performance status, and recovery from prior treatment side effects. Patients are monitored for adverse events, safety, and treatment response. The study also ensures participants and their partners use contraception if of childbearing potential, and participants must be accessible for treatment and follow-up visits to document outcomes and safety data.

Researchers are evaluating the effects of a unique mindfulness practice combined with energized water drinking on adults with unipolar depression. This study aims to understand whether tracing Tao Calligraphy called "Greatest Love" while listening to or singing Tao Song, alongside drinking energized water, can improve both subjective and clinical symptoms of depression. The study uses established questionnaires such as the SF-36 Quality of Life, PHQ-9, and Beck Anxiety Inventory to measure changes in well-being, depression, and anxiety over time. Participants will be randomized into practice and control groups. Those in the practice group will engage daily for six weeks in mindfulness practice with Tao Art, which involves tracing calligraphy with their fingers while listening to or singing the Tao Song for 30 minutes. They will also drink about one liter of energized water daily, which is prepared through subtle energy transmission in a dedicated bottle. The control group will not perform these interventions. Assessments are conducted at baseline, six weeks, and twelve weeks. During the study, participants will complete three questionnaires to track changes in quality of life, depression, and anxiety symptoms. The main outcomes measured include the mean change from baseline in these scores after six weeks of practice. Researchers will analyze the data statistically to determine if improvements are significant. Participants must comply with daily mindfulness and water drinking practices and data collection requirements throughout the study duration.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.