New London

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are comparing two approaches of standard therapy for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. This phase III trial evaluates whether giving chemotherapy and immunotherapy before and after surgery (perioperative) is more effective than giving the same treatments only after surgery (adjuvant). The study aims to find out which method leads to better event-free survival and overall survival over several years. Participants are randomly assigned to one of two groups. In the adjuvant group, patients have surgery first, followed by up to four cycles of platinum-based chemotherapy and up to one year of immune checkpoint inhibitor treatment if there is no disease progression or unacceptable side effects. In the perioperative group, patients receive chemotherapy combined with immune checkpoint inhibitors before surgery, then have surgery, and continue immune checkpoint inhibitor therapy for up to one year afterward. Chemotherapy drugs used may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine, and immunotherapy drugs may include nivolumab, pembrolizumab, or atezolizumab. During the study, patients undergo imaging tests such as CT scans, MRI, or PET/CT scans to monitor their condition. After completing treatment, they are followed for up to 10 years with check-ups every six months. Researchers measure event-free survival at three years, overall survival up to 10 years, surgical outcomes, side effects, and other treatment-related factors to understand which approach offers better results for patients with resectable NSCLC.

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 two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Researchers are studying how social and genetic factors affect outcomes for adolescent and young adult (AYA) survivors of Hodgkin and non-Hodgkin lymphoma. Compared to children and older adults, AYAs with these cancers face unique biological, clinical, psychological, and social challenges that influence their risk of illness and early death after treatment. By collecting blood samples and detailed health and treatment information, the study aims to better understand these risks and improve support for AYA cancer survivors. Participants in this observational study provide blood samples and complete health-related quality of life questionnaires at the start of the study and again at 6, 12, 18, and 24 months. The study examines how social-environmental risk factors and individual resilience relate to disease-free survival, overall survival, and quality of life. It also explores how gene expression changes may mediate these effects and whether factors like race, sex, gender identity, and geography influence outcomes. Throughout the two-year period, researchers monitor participants for disease-free survival, overall survival, and comorbidities including symptoms and late effects. The study collects repeated assessments through questionnaires and blood draws to track health status, quality of life, and biological markers. This comprehensive approach helps identify factors that impact long-term health for adolescent and young adult lymphoma survivors.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) designed to help patients who have had surgery for stage II or III colorectal cancer receive follow-up care that follows current medical guidelines. This phase III trial aims to see if CTAC improves patients' knowledge about surveillance, their confidence in managing their care, and satisfaction with support received from a chosen adult supporter. Proper surveillance after colorectal cancer surgery is important to detect any return of the disease early, but many survivors do not receive recommended follow-up care, possibly due to lack of information or support. Participants are randomly assigned to one of two groups. One group receives access to the CTAC intervention website, which includes educational content and interactive modules to help manage post-surgery surveillance. The other group accesses a control website with general health education. Both patients and their chosen supporters can use their assigned website as often as they like for up to 16 months. Supporters are adult individuals identified by the patient who help with their cancer journey. During the study, researchers will measure how many patients receive surveillance care that follows guidelines at 12 and 16 months. They will also assess patients' knowledge about surveillance, confidence in managing their care, and satisfaction with supporter involvement at 3 and 16 months. Surveys and interviews will be conducted to gather this information. The study will also explore how well the intervention fits into clinical practice and how supporter participation affects outcomes.

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 connected customized treatment platform called CONCURxP to help patients with metastatic breast cancer adhere to their CDK4/6 inhibitor medication schedules. The study compares CONCURxP, which combines a WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. This research aims to improve medication adherence, symptom management, quality of life, and communication between patients and providers over a 12-month period. Participants are randomly assigned to one of two groups: Arm A uses the WiseBag and receives educational materials every four weeks for 12 months, while Arm B uses the WiseBag along with personalized text message reminders and healthcare provider follow-ups as part of the CONCURxP program. Patients in Arm B may also complete an interview within six months after study completion. A separate group, Arm C, includes non-patient participants who complete an interview 15 to 39 months after the first patient enrollment. After the intervention period, patients may be monitored for an additional six months. During the study, participants' medication adherence is tracked electronically using the WiseBag at 12 months after starting medication. Researchers also assess self-reported adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, financial worry, healthcare use, and survival outcomes. Patient interviews and electronic health record reviews support the collection of these data. The study involves surveys, text messaging, medication tracking, and follow-ups to understand and improve adherence and overall patient experience.