Iron Mountain

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

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.

Researchers are evaluating the effect of the Cost Communication and Financial Navigation CostCOM intervention on adherence to cancer care and financial burden in patients with malignant solid neoplasms. This study focuses on how financial hardship caused by out-of-pocket costs, employment changes, and insurance affects cancer treatment and quality of life. CostCOM aims to provide financial counseling and resource connections to reduce these burdens and improve adherence to care. Participants are randomized into two groups. One group receives a brochure describing financial navigation services Enhanced Usual Care, while the other group receives usual financial care plus CostCOM financial counseling sessions within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants complete surveys and participate in interviews 15 to 39 months after the first patient enrollment. Participants complete surveys at baseline and at 3, 6, and 12 months to report on cost-related care non-adherence, financial hardship, financial worry, quality of life, and satisfaction with care. The study includes follow-up for 12 months after intervention completion. Non-patient participants also provide feedback on the CostCOM intervention through interviews. Researchers will monitor patient experiences and financial outcomes throughout the study.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

This research aims to better understand cancer cachexia CC, a condition involving weight, muscle, and fat loss that affects patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. CC is linked to reduced physical function, lower quality of life, and poorer survival. The study seeks to identify different subtypes of CC based on patient characteristics to improve diagnosis and tailor treatments more effectively than a one-size-fits-all approach. It also aims to validate these subtypes and explore tumor factors that may contribute to CC. Participants will complete surveys and physical function tests lasting about 30 minutes each, provide blood samples and archived tumor tissue, and wear an actigraph device for 7 days to monitor sleep and activity. These assessments occur at the start of the study and again after three months. Standard imaging scans such as CT or PETCT are performed as part of usual care throughout the study. Medical records are reviewed at baseline, 3 months, and 1 year to collect comprehensive clinical data. During the study, researchers will evaluate physical function, symptoms, body composition, blood biomarkers, and activity levels to identify distinct CC diagnostic subtypes and their association with survival. Surveys and functional tests help measure symptoms and physical ability. The actigraph tracks daily activity and sleep patterns. The study follows participants for up to one year to monitor changes and outcomes, aiming to build a detailed database to support future research and clinical trials for cancer-related weight and muscle loss.

Researchers are evaluating a connected customized treatment platform called CONCURxP to improve medication adherence in patients with metastatic hormone receptor-positive, HER2-negative breast cancer who are taking CDK46 inhibitors. The study compares CONCURxP, which includes the 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. The purpose is to see if these approaches affect how well patients follow their medication schedules, symptom burden, quality of life, and other outcomes over 12 months. Participants are randomly assigned to one of two groups Arm A uses the WiseBag dispenser and receives educational materials every 4 weeks for 12 months, while Arm B uses the WiseBag plus receives personalized text reminders, medication tracking, and provider follow-ups through CONCURxP for 12 months. A third group Arm C involves non-patient participants completing interviews 15 to 39 months after the first patient enrollment. After the 12-month intervention period, patients may be followed for an additional 6 months. During the study, patients complete surveys and electronic monitoring to assess medication adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, and financial worry at multiple time points. Some participants may also complete interviews about their experiences. Researchers review healthcare utilization, progression-free survival, and overall survival at 12 months. The study involves continuous monitoring using the WiseBag device and regular follow-ups to measure adherence and related outcomes.

Researchers are studying the relationship between low muscle mass myopenia at diagnosis and chemotherapy side effects in older adults newly diagnosed with advanced colorectal cancer. This prospective cohort study also investigates how genetic differences may influence the link between myopenia and chemotherapy toxicity, focusing on overall survival in this population receiving specific chemotherapy treatments. Participants in this observational study are older adults with metastatic colorectal cancer who are starting or recently started 5-Fluouracil 5-FU based chemotherapy, alone or combined with other drugs like oxaliplatin, irinotecan, or immunotherapy. The study groups include adults aged 60-74 years and those 75 years or older. The study tracks chemotherapy toxicities over 6 months following treatment initiation. During the study, participants will be monitored for chemotherapy toxicities graded 3 to 5 and overall survival for up to one year. Researchers will collect information through questionnaires available in English or Spanish and assess the impact of muscle mass and genetics on treatment side effects and survival. The total participation time varies, with ongoing assessments during and after chemotherapy treatment.