South Pasadena

Researchers are evaluating a blended e-health intervention designed to reduce fear of progression FOP in women with advanced gynecologic or breast cancer. This trial focuses on whether a combination of remote group sessions and online activities can help women manage their fear of cancer worsening, which is a common and distressing concern. The study aims to assess the feasibility and acceptability of this approach alongside its effects on FOP and related psychological symptoms such as distress and anxiety. Participants are randomly assigned to one of two groups for a 6-week program. The Mindful Living Program group attends three 60-minute group sessions during weeks 1, 3, and 6 and completes online sessions in weeks 2, 4, and 5. They practice mindfulness and coping skills daily for 10-12 minutes, receive a check-in call around week 3 or 4, and have access to supportive online resources. The comparison group participates in the Navigating Cancer Program with a similar schedule of group and online sessions plus a check-in call but without the daily mindfulness practice or additional online tools. During the study, participants complete questionnaires measuring fear of progression, distress, anxiety, mindfulness, and other psychological outcomes at the start, after 6 weeks, and at 12 weeks follow-up. Researchers monitor attendance, engagement, and usability of the intervention over 6 weeks and conduct follow-up assessments at week 12. The total participation time includes the 6-week intervention period plus follow-up, with safety and usability being key measures.

Researchers are evaluating how cannabis use affects the quality of life in patients with multiple myeloma who are receiving chemotherapy. This observational study compares patients who use cannabis with those who do not, aiming to understand both potential benefits and harms. It uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma FACT-MM and patient-reported symptoms to assess these effects over time. Participants are divided into two groups one group completes surveys and provides blood samples throughout the study, and the other group consists of healthcare providers who complete a survey related to the study. The study follows participants for up to one year, focusing on longitudinal patterns in quality of life and the potential therapeutic benefits and adverse effects associated with cannabis use. During the study, patients complete questionnaires and provide blood samples regularly. Researchers monitor their symptoms and any side effects using standardized scales such as the Edmonton Symptoms Assessment Scale and Common Terminology Criteria for Adverse Events. The study tracks changes over time to better understand how cannabis use interacts with cancer-directed treatments and overall patient well-being.

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

This research aims to evaluate the side effects of abemaciclib monotherapy in patients aged 70 years and older who have hormone receptor positive, HER2 negative metastatic breast cancer that has spread to other parts of the body. The study focuses on estimating the occurrence of severe toxicities grade 3 or higher and describing the full range of side effects, patient-reported adverse events, and treatment adherence. Researchers will also explore the relationship between geriatric assessment scores, aging biomarkers, and toxicity levels. Participants receive abemaciclib orally twice daily in 28-day cycles until disease progression or unacceptable side effects occur. After completing treatment, patients are followed up at 30 days and then every six months for two years. The study includes questionnaires assessing treatment impact and collects blood samples to measure drug concentrations. Throughout the trial, participants undergo regular evaluations including toxicity assessments, dose changes, hospitalizations, and survival outcomes. Researchers will monitor treatment adherence and patient quality of life using specific questionnaires. Follow-up visits continue for two years post-treatment to collect data on long-term effects, disease progression, and survival rates.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

This research evaluates the combination of pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to prevent the need for surgery to remove the bladder cystectomy following standard chemotherapy that aims to shrink or eliminate the tumor. This phase II trial focuses on bladder preservation and improving survival without bladder removal in this patient group. Participants receive photon beam radiation therapy daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given intravenously on the first day of each 21-day cycle, for up to 18 cycles totaling 12 months, including the prior chemotherapy phase. Before and during treatment, patients undergo tissue collection via transurethral resection of bladder tumor TURBT, imaging scans such as CT, MRI, or PET, as well as cystoscopy and urine and blood tests. Throughout the study, patients are monitored for treatment effects, tumor recurrence, metastasis, and overall survival, with assessments of side effects and patient-reported symptoms related to gastrointestinal, urinary, and sexual function. After treatment, follow-up visits occur every 26 weeks until two years, then annually up to five years. Specimens are also collected for future research. The main outcome measured is bladder intact event-free survival within three years after registration.

Researchers are comparing two monoclonal antibody treatments, rituximab and mosunetuzumab, for adults with previously untreated follicular lymphoma that has a low tumor burden. The study aims to understand which treatment better controls disease progression and improves outcomes over time. Both drugs target cancer cells but work differently, and this phase III trial evaluates their effectiveness and safety. Participants are randomly assigned to one of two groups. One group receives rituximab intravenously and subcutaneously in cycles repeating every 56 days for up to five cycles unless the disease progresses or side effects become unacceptable. The other group receives mosunetuzumab subcutaneously in cycles repeating every 21 days for up to eight cycles under similar conditions. During treatment, patients undergo CT or PETCT scans and blood tests to monitor their disease and health. After completing the treatment phase, participants are followed with visits every six months for five years, then annually up to ten years. Researchers collect imaging and blood samples during and after treatment to assess progression-free survival and other health outcomes, including overall survival and treatment side effects. This long-term follow-up helps understand the treatments lasting effects and safety.