Danvers

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

This trial focuses on both women and men diagnosed with Stage I HER2-positive invasive breast cancer. It aims to compare two different combinations of HER2-targeted therapies given after surgery, studying how well each treatment controls the cancer and their side effects. The study is a randomized phase II trial supported by Genentech and led by the Dana-Farber Cancer Institute, evaluating long-term benefits and disease-free survival over several years. Participants are randomly assigned to one of two groups. One group receives six cycles of intravenous trastuzumab-emtansine T-DM1 every three weeks, followed by eleven cycles of subcutaneous trastuzumab every three weeks. The other group receives weekly intravenous paclitaxel for twelve weeks along with subcutaneous trastuzumab every three weeks, continuing trastuzumab alone for additional cycles. The entire treatment period lasts about one year. During the study, participants undergo screening and regular laboratory evaluations along with follow-up visits. Researchers monitor side effects, quality of life, symptoms related to therapy, and cardiac function. The main outcomes measured include the incidence of toxicities during the first 18 weeks and disease-free survival over up to 72 months. Participants are followed for five years after treatment to assess long-term outcomes and safety.

Researchers are evaluating the effectiveness of an electronic decision aid tool compared to traditional genetic counselor sessions for multi-gene panel testing in people diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma. This randomized study is supported by the National Cancer Institute and aims to help patients better understand genetic testing options and support shared decision making. Participants are randomly assigned to one of two groups one group uses the electronic decision aid followed by an appointment with their oncologist, while the other receives pretest counseling from a genetic counselor. Both groups complete several questionnaires including a Knowledge Survey, Shared Decision Making Process Survey, and Decisional Conflict Scale. The study duration is up to two weeks. During the study, participants complete surveys before and about one week after their genetics sessions to assess knowledge, decision conflict, and shared decision making. Researchers also track the time between genetic testing recommendation and sample collection, the duration of the decision-making process, and choices made regarding genetic testing panels. Approximately 350 people are expected to participate in this research.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the drug ruxolitinib in people with low-risk but symptomatic essential thrombocythemia ET and polycythemia vera PV. This phase II clinical trial aims to see if ruxolitinib can reduce the symptoms caused by these blood conditions. The study is supported by a biopharmaceutical company and involves patients diagnosed according to specific medical criteria and who have significant symptoms. Participants will receive ruxolitinib pills taken twice daily in 28-day treatment cycles. The trial includes two stages in the first stage, participants receive six cycles of ruxolitinib, and if at least three participants respond positively, the second stage will proceed with similar treatment. Those benefiting from the drug may continue treatment as long as side effects or disease progression do not occur. During the study, participants will undergo screening, evaluations, and follow-up visits. Researchers will measure symptom changes using the Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score over 12 weeks as the primary outcome. Other assessments include blood counts, spleen volume, and monitoring of treatment-related side effects. The total study duration and ongoing monitoring may extend up to 60 months.

Researchers are evaluating sacituzumab govitecan for people with localized triple negative breast cancer TNBC in this Phase II clinical trial. The study aims to assess the safety and effectiveness of this investigational drug, alone or combined with pembrolizumab, in treating this specific type of breast cancer. This trial is part of an umbrella study exploring different treatment options for breast cancer patients, including future arms for hormone receptor positive and inflammatory breast cancers. Participants will receive sacituzumab govitecan through intravenous infusions on two days every 21-day cycle, for up to four cycles approximately 12 weeks. After completing the sacituzumab govitecan monotherapy cohort, a combination therapy cohort with pembrolizumab will open. Some participants may also receive standard chemotherapy afterward, based on their doctors decision. The study includes screening, treatment, evaluations, and follow-up visits. During the study, participants will undergo various assessments including biopsies, laboratory tests, and evaluations to monitor response and safety. Researchers will measure outcomes such as the pathological complete response rate at 12 weeks, disease-free survival, overall survival, quality of life, and treatment-related side effects. The total participant involvement may last up to 36 months for long-term monitoring of outcomes and safety.

Researchers are evaluating the effects of oral rilzabrutinib in adults with immune thrombocytopenia ITP who have not responded to first-line treatment. This multinational, open-label, single-arm study focuses on early multi-immune modulation to manage ITP symptoms and improve platelet response. The trial is sponsored by Sanofi and is designed as a Phase 3 treatment study. Participants will receive rilzabrutinib tablets orally at a dose of 400 mg twice daily. The study is divided into several periods a screening phase lasting up to 8 weeks, a primary analysis phase of up to 28 weeks where the main treatment effects are assessed, followed by a long-term extension phase of 28 weeks for selected participants. Additionally, there is a 24-week follow-up period for eligible participants after treatment. During the study, participants will be monitored regularly to evaluate platelet response and bleeding symptoms using the immune thrombocytopenia bleeding scale, as well as their ability to reduce corticosteroid doses. Safety assessments will track adverse events and clinically significant abnormalities throughout the study, including the extension and follow-up phases. The total duration of participation may extend up to approximately 80 weeks, depending on individual eligibility for the long-term and follow-up periods.