Lowell

Researchers are evaluating the use of 3D scanning and 3D printing technology to create a custom wrist and hand orthosis for people with Ehlers-Danlos Syndrome EDS. The study aims to see if this new orthosis can improve quality of life by supporting unstable joints, reducing pain, and decreasing the number of wrist dislocations and subluxations. This could also help reduce fear and anxiety related to these joint issues and improve mental health. The study involves making a custom 3D-scanned and 3D-printed wrist-hand orthosis tailored to each participants anatomy using biomedically safe materials. This device is designed to provide better support compared to existing prefabricated orthoses. Investigators will use high-definition 3D scanning and printing technology to ensure a precise fit and will customize the orthosis based on participant feedback for comfort and effectiveness. Participants will be evaluated from enrollment through 8 weeks of wearing the orthosis. Researchers will measure wrist joint stability, changes in pain levels using a 0-100 pain scale, activity participation with tools like the Health Assessment Questionnaire, and satisfaction with the device using the OPUS survey. These assessments will help determine the impact of the orthosis on function, pain, daily activities, and overall quality of life for people with EDS.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are evaluating the feasibility and early effects of a new meal kit and nutrition education program among adults aged 40 and older with lower income. The study aims to see if this program can improve food security, diet quality, mental health, quality of life, and heart-related health factors compared to standard printed nutrition materials. Participants have obesity and at least one related health condition such as high blood pressure or elevated glucose levels. Participants will be randomly assigned to one of two groups. One group receives weekly meal kits with ingredients and instructions to prepare three meals per week for 12 weeks, along with nutrition education delivered via print or online resources. The other group receives standard printed materials and recipes about healthy eating weekly. The meal kits are designed to reduce barriers like meal planning and grocery shopping. Participants will be assessed at the start and after 12 weeks for food insecurity, diet quality, stress, anxiety, depression symptoms, quality of life, blood pressure, body measurements, and glucose variability. The study involves questionnaires and health measurements to evaluate the programs impact. The trial continues until October 2026, with all procedures conducted in the Greater Lowell area to support meal kit deliveries and data collection.

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 conducting a study to evaluate the feasibility and acceptability of collecting patient-reported outcomes PROs from adolescents and young adults AYAs aged 18 to 39 who have been diagnosed with cancer. The study compares two approaches allowing participants to choose five health-related quality of life HRQOL domains they find most important Choice PRO versus completing five standard HRQOL domains selected by researchers Fixed PRO. The goal is to understand which method better supports AYA engagement and data completion. Participants are randomized into two groups. One group selects five from 15 PRO domains to complete at baseline and at 1, 3, 6, and 12 months, while the other group completes a fixed set of five domains at the same intervals. Questionnaires are completed online, facilitated by reminders via calls and text messages to improve adherence. The study also explores AYA preferences on how their PRO data should be shared with themselves, their families, and healthcare providers. During the study, participants complete assessments online at multiple timepoints, including baseline, 1, 3, 6, and 12 months, using a mix of computerized adaptive tests and static forms. Researchers measure feasibility based on the percentage of completed PROs and participant acceptability. The study monitors response rates, preferences, and data sharing views, aiming to enhance future patient-centered care and support in clinical trials involving AYAs with cancer.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

This research aims to compare two ventilation strategies in patients with Acute Respiratory Distress Syndrome ARDS, a serious lung condition with high mortality despite recent advances. The study evaluates whether a personalized lung-stress oriented ventilation approach can improve survival compared to standard mechanical ventilation. This is a phase III, multi-center, randomized controlled trial designed to assess outcomes such as mortality, lung injury, and hemodynamic safety. Participants will receive one of two ventilation methods the precision ventilation strategy, which adjusts ventilator settings based on driving pressure and esophageal manometry to keep lung stress within a normal range, or guided usual care, where ventilator settings follow standard best-practice guidelines with some protocol limits. The precision strategy involves careful titration of tidal volume, positive end-expiratory pressure PEEP, and oxygen levels to reduce lung injury, while the usual care arm allows clinicians to manage ventilation within established targets. During the study, participants will be monitored for 60 days to measure mortality and other outcomes such as ventilator-free days, respiratory support-free days, and incidence of barotrauma. Researchers will collect clinical data on lung injury and hemodynamic stability, including shock-free days through Day 14. The trial includes randomization, and participants will be followed closely through the course of their ventilation treatment and recovery period. The total duration of involvement varies depending on clinical course and survival.

Researchers are collecting data on patients with Epidermal Growth Factor Receptor EGFR-mutant Non-Small Cell Lung Cancer NSCLC who are treated outside of a clinical trial with standard care using osimertinib alone or combined with chemotherapy. The goal is to better understand the safety and effectiveness of these treatments as they are used in routine clinical practice. This is an observational study recruiting about 250 patients per treatment group, including those receiving osimertinib alone or osimertinib plus chemotherapy. Patients are treated according to standard medical care as determined by their doctors. One group receives osimertinib by mouth once daily, while the other group receives osimertinib plus chemotherapy, with chemotherapy type chosen by the treating physician. Treatment dosing and administration follow standard guidelines. The study records planned treatments at registration and observes outcomes without altering the care given. Participants will have clinical and imaging assessments as part of their usual care, with data collected on their health and treatment progress. Researchers will measure real-world progression-free survival, overall survival, and time to stopping osimertinib for up to three years. The study follows participants over time to monitor how they respond to therapy and to gather safety information.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.