Danvers

This research aims to evaluate the feasibility and acceptability of a brief psychotherapy program designed to help young adults aged 25 to 39 with cancer and their caregiving partners improve their coping skills and maintain their relationships. The study focuses on addressing the unique challenges faced by young adults with cancer and the burden and low self-confidence experienced by their partners in caregiving. This pilot trial will include 10 young adults with cancer along with their partners, totaling 20 participants. The intervention involves eight sessions based on cognitive-behavioral therapy and couples-focused therapy principles, tailored specifically for young adults. It is delivered by a trained mental health professional and includes educational content, hands-on exercises, and assignments to practice at home. Participants will receive this structured support to enhance their ability to manage cancer-related stress and strengthen their relationship during and after treatment. Participants will complete surveys before starting the intervention and after finishing it to assess its feasibility and acceptability. They will also have the option to participate in semi-structured interviews to provide further feedback. The study's outcomes focus on measuring how practical and well-received the intervention is over approximately 14 weeks. This information will guide improvements for future larger-scale clinical trials.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are investigating treatments for people with newly diagnosed Stage I HER2-positive invasive breast cancer. This phase II study compares two different combinations of HER2-targeted therapies after surgery to evaluate their effects and side effects. The study focuses on whether trastuzumab-emtansine (T-DM1) followed by subcutaneous trastuzumab has fewer side effects than the standard treatment of paclitaxel combined with subcutaneous trastuzumab, while also looking at long-term benefits and disease-free survival. Participants will be randomly assigned to one of two groups. One group will receive trastuzumab-emtansine (T-DM1) through intravenous infusion followed by subcutaneous trastuzumab injections. The other group will receive paclitaxel through intravenous infusion combined with subcutaneous trastuzumab injections. Treatments will be given for a total of one year. T-DM1 is a targeted therapy that combines an antibody with chemotherapy to directly attack cancer cells. During the study, participants will undergo screening, laboratory tests, and regular follow-up visits over five years after treatment ends. Researchers will monitor side effects during the first 18 weeks of treatment and measure disease-free survival up to 72 months. The study includes assessments of heart function, blood tests, and collection of tumor tissue for research. About 500 people are expected to participate.

Researchers are evaluating an electronic decision aid tool compared to traditional genetic counselor sessions for people with ovarian or pancreatic cancer considering multi-gene panel testing. This randomized trial aims to assess how these two approaches affect participants' knowledge, decision-making conflicts, and shared decision-making processes. The study is supported and funded by the National Cancer Institute and expects to enroll about 350 participants. Participants will either use an electronic decision aid followed by an appointment with an oncologist or receive pre-test counseling from a genetic counselor. Both groups will complete surveys and questionnaires related to their experience. These interventions are behavioral and designed to help participants make informed choices about genetic testing. The study lasts up to two weeks, during which participants will complete questionnaires including a Knowledge Survey, Shared Decision Making Process Survey, and Decisional Conflict Scale. Researchers will measure changes in knowledge, decision conflict, and shared decision-making one week after the genetics session. Eligibility screening and data collection will occur alongside participants' clinical visits at specified hospitals.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the drug ruxolitinib in a phase II clinical trial for people with low-risk but symptomatic essential thrombocythemia (ET) and polycythemia vera (PV). The study aims to see if ruxolitinib can reduce symptoms experienced by these patients. Ruxolitinib works by blocking specific proteins that may cause symptoms in ET and PV. This multi-center study expects to enroll about 60 participants and is supported by the biopharmaceutical company Incyte. Participants will receive ruxolitinib pills taken by mouth for about 6 months. If the treatment benefits them without unacceptable side effects or disease progression, they may continue taking the drug for a longer period. The study includes a screening phase for eligibility followed by treatment and follow-up visits to monitor progress. During the study, participants will undergo evaluations including symptom assessments and laboratory tests to monitor organ and bone marrow function. Researchers will measure the percentage of patients who achieve more than a 50% reduction in their symptom score from baseline to 12 weeks. Safety and treatment adherence will also be monitored throughout the study.

Researchers are evaluating sacituzumab govitecan, alone and combined with pembrolizumab, for people with localized triple negative breast cancer (TNBC) in this Phase II clinical trial. The study aims to test the safety and effectiveness of these drugs, which are investigational and not yet FDA-approved for metastatic TNBC. Sacituzumab govitecan is an antibody-drug conjugate that targets cancer cells to prevent their growth and spread. Participants will receive sacituzumab govitecan intravenously every 21 days for up to 12 weeks, with four treatment cycles planned in the monotherapy group. After enrollment of this group, a combination therapy group receiving sacituzumab govitecan plus pembrolizumab will open. Following study treatment, standard chemotherapy may be given based on the treating physician's judgment. During the study, participants will undergo screening and regular evaluations including laboratory tests and follow-up visits. Researchers will assess the pathological complete response rate after 12 weeks of treatment. About 50 people are expected to participate, and the study includes close monitoring of safety and treatment effects throughout the trial.