Selinsgrove

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

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 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 investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are studying how low muscle mass, known as myopenia, affects chemotherapy side effects and overall survival in older adults newly diagnosed with advanced colorectal cancer. The study also looks at how genetic differences might influence the link between myopenia and chemotherapy toxicity. This research focuses on patients receiving 5-Fluorouracil (5-FU) based chemotherapy, sometimes combined with other drugs or immunotherapy. The study includes older adults with metastatic colorectal cancer who are starting or have recently started first-line treatment with 5-FU chemotherapy, alone or combined with oxaliplatin, irinotecan, or immunotherapy. Capecitabine is also allowed. The study tracks patients over time to observe chemotherapy side effects and survival, but there are no specific investigational treatments or devices involved. Participants will be monitored for chemotherapy toxicities, especially those graded 3 to 5, for up to 6 months after starting treatment. The study collects data on muscle mass, genetic factors, and treatment outcomes to understand how these affect chemotherapy side effects and survival. Participants must be able to complete questionnaires in English or Spanish and provide consent to join the study.

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 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.

Researchers are evaluating the effects of several targeted drugs—vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib—on patients with progressive meningiomas that have specific genetic mutations. This phase II trial focuses on tumors that are growing, spreading, or worsening despite prior treatment. The study aims to measure how well these drugs work in slowing tumor progression and improving response rates, especially in patients whose tumors have mutations in SMO, PTCH1, NF2, AKT1, PIK3CA, PTEN, and CDK-related pathways. Patients are assigned to one of four treatment groups based on their tumor's genetic mutation profile. Those with SMO or PTCH1 mutations receive vismodegib daily by mouth, those with NF2 mutations receive the FAK inhibitor GSK2256098 twice daily, patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily for four days each week, and those with CDK pathway alterations receive abemaciclib every 12 hours. Each treatment cycle is 28 days, continuing unless the disease worsens or side effects become unacceptable. After treatment ends, patients are followed every six months for up to five years. Participants undergo various assessments including imaging scans and genetic testing to confirm eligibility and monitor tumor status. Researchers track progression-free survival at six months and response rates up to two years. Safety is monitored through adverse event reporting and lab tests. The study also collects data on overall survival and treatment tolerability. Patients are carefully evaluated before and during treatment to ensure safety and measure the drugs' effects on tumor growth and patient health over time.