Iron Mountain

Researchers are evaluating an Internet-based pain coping skills program combined with enhanced usual care to see if it improves pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also investigates how this program affects opioid and other pain medication use, quality of life, self-confidence in managing pain, and other factors such as fatigue, sleep, emotional distress, and cognitive function. The study plans to enroll 250 participants who have had invasive cancer treated with surgery, radiation, chemotherapy, or other therapies. Participants in the study will be randomly assigned to either receive the 8-session Internet-based pain management program along with enhanced usual care or receive enhanced usual care alone. The program is designed to help participants better manage their cancer-related pain through online sessions. Each participant will be involved for about 9 months, from the initial randomization to the final follow-up assessment at week 34. During the study, participants will complete assessments evaluating pain severity and pain interference using the Brief Pain Inventory. Researchers will also measure medication use, quality of life, pain management confidence, and other health factors through questionnaires and interviews. Participants are expected to complete follow-up assessments at 22 and 34 weeks. The study includes monitoring for safety and adherence to the pain management program, and those without reliable internet access may receive tablets to participate.

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 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 studying cancer cachexia (CC), a syndrome involving weight, muscle, and fat loss in patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. This study aims to identify different diagnostic subtypes of CC based on host characteristics such as symptoms, physical activity, blood biomarkers, and body composition. The goal is to better understand the varied causes of CC to improve diagnosis and develop more effective treatments tailored to individual patients. Participants will complete surveys and physical function tests that each take about 30 minutes. They will provide blood and archived tumor samples and wear a device called an actigraph for 7 days to monitor sleep and activity. Standard care scans like CT or PET/CT will be done during the study. Data will be collected at the start and again at 3 months, with continued review of medical records up to 1 year. These procedures help researchers study changes in CC characteristics over time and explore tumor factors linked to this condition. During the study, patients will undergo assessments of weight, muscle loss, symptoms, physical activity, and function. Researchers will analyze blood samples, tumor tissue, and medical images while reviewing health records. The main outcome is identifying distinct CC subtypes and their association with survival. Follow-ups occur at 3 months and 1 year to track changes and outcomes. The study involves no treatment but focuses on observation and data collection to support future CC diagnosis and therapy improvements.

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.